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Pulse Oximeter System MODEL 7500, 8000AA, PCS-AU

by Nonin Medical, Inc. 17 variants

Ref 7500-0204, 7500-0803, 7500-1301, 7500-1702, 7500-1502, 7500-1601, 7500-1603, 7500-0005, 7500-0101, 7500-1501, 7500-1101, 7500-0301, 7500-1302, 7500-1203, 7500-0302, 7500-1304, 7500-0102, 7500-0203, 7500-1403, 7500-1401, 7500-1201, 7500-0404, 7500-0504, 7500-0201Model MODEL 7500, 8000AA, PCS-AU, MODEL 7500, 8000J, PCS-EU, MODEL 7500, 8000SS-3, PCS-US, MODEL 7500, 8000SL-3, PCS-UK, MODEL 7500, 8000SM-3, PCS-UK, MODEL 7500, 8000SL, PCS-USPulse Oximeter System, MODEL 7500, 8000SL, PCS-EU, MODEL 7500, NO SENSOR, PCS-AU, MODEL 7500, 8000AA-3, PCS-US, MODEL 7500, 8000SM-3, PCS-US, MODEL 7500, 8008J, PCS-US, MODEL 7500, 8000AA-2, PCS-US, MODEL 7500, 8000SS-3, PCS-UK, MODEL 7500, 8000SS, PCS-EU, MODEL 7500, 8000AA-2, PCS-UK, MODEL 7500, 8000SS-3, PCS-AU, MODEL 7500, 8000AA-3, PCS-UK, MODEL 7500, 8000AA, PCS-EU, MODEL 7500, 8000SM, PCS-EU, MODEL 7500, 8000SM, PCS-US, MODEL 7500, 8000SS, PCS-US, MODEL 7500, 8000AP, PCS-AU, MODEL 7500, 8000AP-3, PCS-AU, MODEL 7500, 8000AA, PCS-US

Active European Union and United States

CE MDD 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K191403↗

+4 more

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00849686066883 Basic UDI-DI Date12 Dec 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK191403 Date20 Dec 2019IssuedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDD Active

Specification

EUDAMED · 510(k)

Full name
Pulse Oximeter System
Model / Reference
MODEL 7500, 8000AA, PCS-AU, 7500-0204, 8000J, PCS-EU, 7500-0803, 8000SS-3, PCS-US, 7500-1301, 8000SL-3, PCS-UK, 7500-1702, 8000SM-3, 7500-1502, 8000SL, PCS-USPulse Oximeter System, 7500-1601, 7500-1603, NO SENSOR, 7500-0005, 8000AA-3, 7500-0101, 7500-1501, 8008J, 7500-1101, 8000AA-2, 7500-0301, 7500-1302, 8000SS, 7500-1203, 7500-0302, 7500-1304, 7500-0102, 7500-0203, 8000SM, 7500-1403, 7500-1401, 7500-1201, 8000AP, 7500-0404, 8000AP-3, 7500-0504, 7500-0201
Primary DI / UDI-DI
00849686066883, 00849686098457, 00833166004977, 00849686098358, 00833166007633, 00833166007664, 00849686098365, 00849686066111, 00833166002683, 00833166002829, 00833166002799, 00849686066746, 00833166007565, 00849686098402, 00849686098532, 00849686066814, 00833166002690, 00849686098549, 00849686098389, 00833166004960, 00849686066708, 00849686066869, 00849686066852, 00833166007183
Basic UDI-DI
B-00849686066883, B-00849686098457, B-00833166004977, B-00849686098358, B-00833166007633, B-00833166007664, B-00849686098365, B-00849686066111, B-00833166002683, B-00833166002829, B-00833166002799, B-00849686066746, B-00833166007565, B-00849686098402, B-00849686098532, B-00849686066814, B-00833166002690, B-00849686098549, B-00849686098389, B-00833166004960, B-00849686066708, B-00849686066869, B-00849686066852, B-00833166007183
EMDN Code
Z1203020408, C900301
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000008228
Authorised representative
MPS Medical Product Service GmbH DE-AR-000005009

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

This device is a Pulse Oximeter System (Nomenclature Code: Z1203020408), a Class IIb medical device designed to non-invasively measure oxygen saturation (SpO₂) in arterial blood and pulse rate. It employs photoplethysmography to detect light absorption variations in tissue, providing real-time monitoring of oxygenation levels and heart rate for clinical assessment.

The system is non-sterile, non-reusable, and non-implantable, intended for single-use applications in hospital, clinical, and home-care settings. It operates without active medication administration or latex components and is supplied with a unique Basic UDI (B-00849686066883) for traceability. Authorized under FDA 510(k) and MDD compliance, it adheres to regulatory standards for non-invasive monitoring devices.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What clinical measurements does this pulse oximeter system provide, and how does it achieve them?

    This Pulse Oximeter System measures oxygen saturation (SpO₂) in arterial blood and pulse rate non-invasively. It uses photoplethysmography, a technique that detects variations in light absorption by tissue to monitor oxygenation levels and heart rate in real time, enabling clinical assessment without medication administration or invasive procedures.

  • Is this device reusable, and if not, what are the implications for clinical settings?

    No, this Pulse Oximeter System is designed for **single-use only** and is explicitly marked as non-reusable. Clinicians should dispose of it after one use to ensure patient safety and compliance with regulatory standards, particularly in hospital, clinical, or home-care environments where sterility and infection control are critical.

  • What models are available, and how can I identify the correct UDI for traceability?

    The system comes in three models: **7500, 8000AA, and PCS-AU**. Each model is traceable via its unique **Basic UDI (B-00849686066883)** and associated UDI data (e.g., `01JEXPXYTAEY9VFS57Z2S5DEB9`), ensuring compliance with regulatory requirements for device tracking in healthcare settings.

  • Does this device contain latex or animal-derived components, and what are the storage requirements?

    The Pulse Oximeter System is **latex-free** and does not contain animal tissues. Since it is **non-sterile and single-use**, storage should follow manufacturer guidelines to maintain functionality—typically in a clean, dry environment away from direct sunlight or extreme temperatures until use.

  • How does this device comply with regulatory standards, and who is the authorized representative in Europe?

    The device is authorized under **FDA 510(k)** and **MDD compliance**, meeting regulatory standards for non-invasive monitoring. In Europe, **MPS Medical Product Service GmbH (SRN: DE-AR-000005009)** serves as the authorized representative, ensuring adherence to local market requirements.

Properties

  • Measuring Function

Other properties (10)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No