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Intellivue Cl SP02 Pod (865215 +4 more) - X2 Model

by Philips Medizinsysteme Boeblingen GmbH, Cardiac AN

510(k) K101600

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK101600 Date31 Aug 2010ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQA
Models / Variants
X2 Model
Device Class
Class II
Regulation
21 CFR Part 870.2700
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 Sep 2026

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

The IntelliVue CL SpO2 Pod and CL NBP Pod are wireless devices designed for monitoring physiological patient parameters, including SpO2 and pulse rate. These pods are intended for use in conjunction with IntelliVue Patient Monitors, such as the MP5, MP2, and X2 models, to facilitate patient monitoring and recording.

These devices are intended for use by healthcare professionals in clinical settings. The system has received FDA 510(k) clearance. Users should refer to the specific device manuals for information regarding operation, compatibility, and integration with the IntelliVue monitoring ecosystem.

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Questions

AI-generated answers, 22 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 are the IntelliVue CL SpO2 and NBP Pods used for?

    These wireless pods are designed for healthcare professionals to monitor and record physiological patient parameters, specifically SpO2 and pulse rate, in clinical settings.

  • Which patient monitors are compatible with these pods?

    The CL SpO2 Pod (model 865215) and CL NBP Pod (model 865216) are designed to integrate with the IntelliVue monitoring ecosystem, specifically the MP5, MP2, and X2 patient monitor models.

  • What is the regulatory status of these monitoring devices?

    The IntelliVue CL SpO2 and NBP Pods have received FDA 510(k) clearance, as documented under K-number K101600, confirming they have been found substantially equivalent to existing devices.