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PalmSat Pulse Oximeter System

by Nonin Medical, Inc. 6 variants

Ref 2500-05, 8052-001, 2500A-05, 2500-03, 2500A-17, 2500-17, 2500A-06, 2500A-16, 2500-09, 2500A-13, 2500A-08, 2500A-11Model MODEL 2500, 8000AP-3, MODEL 2500, PALMSAT HANDHELD OXIMETER CONFIGUREABLE, MODEL 2500A, 8000AP-3, MODEL 2500, 8000AA-3, MODEL 2500A, 8000SL-3, MODEL 2500, 8000SL-3, MODEL 2500A, 8000Q2, MODEL 2500A, 8000SL, MODEL 2500, 8000J-3, MODEL 2500A, 8000SS-3, MODEL 2500A, 8000J, MODEL 2500A, 8008J

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 ongoing

2 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K050056↗

+1 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-00849686098716 Basic UDI-DI Date12 Dec 2024RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK050056 Date21 Jun 2005IssuedStatusActive

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

2 recalls · FDA

    • Terminated Z-1092-2008 FDA Unclassified (pre-2012) initiated 15 Oct 2007 on shared 510(k) K002690

    Foreign material: Glass fragments may present in the plastic bag material used to ship components.

    • Terminated Z-0843-2008 FDA Unclassified (pre-2012) initiated 11 Oct 2007 on shared 510(k) K002690

    Incorrect Label: The label on the back of the device may show Model 2500A rather than Model 2500.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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)

Model / Reference
MODEL 2500, 8000AP-3, 2500-05, PALMSAT HANDHELD OXIMETER CONFIGUREABLE, 8052-001, MODEL 2500A, 2500A-05, 8000AA-3, 2500-03, 8000SL-3, 2500A-17, 2500-17, 8000Q2, 2500A-06, 8000SL, 2500A-16, 8000J-3, 2500-09, 8000SS-3, 2500A-13, 8000J, 2500A-08, 8008J, 2500A-11
Primary DI / UDI-DI
00849686098716, 00833166005981, 00849686098662, 00833166007152, 00849686098587, 00849686098686, 00849686098655, 00849686098594, 00849686098709, 00849686098600, 00849686098648, 00849686098624
Basic UDI-DI
B-00849686098716, B-00833166005981, B-00849686098662, B-00833166007152, B-00849686098587, B-00849686098686, B-00849686098655, B-00849686098594, B-00849686098709, B-00849686098600, B-00849686098648, B-00849686098624
EMDN Code
Z1203020408 Pulse oximeters
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

Other devices from Nonin Medical, Inc.

See all devices from Nonin Medical, Inc. →

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