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Philips NM3 Monitor, Model 7900

FDA 510(k)

Class II (US FDA 510(k))

510(k) K091459

by Respironics Novametrix, LLC

Identifiers

510(k) Number
K091459 FDA 510(k)
FDA Product Code
BZK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 868.1850 FDA 510(k)
Regulation Number
868.1850 FDA 510(k)
Advisory Committee
Anesthesiology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Philips NM3 Monitor, Model 7900 is a spirometer, monitoring (with or without alarm) device intended for respiratory monitoring. It provides non-invasive measurement of respiratory parameters including tidal volume, respiratory rate, and end-tidal CO2, and offers a respiratory profile using capnography, volumetric capnography, airway flow and pressure, and pulse oximetry. With the VentAssist option, it delivers graphical data to support ventilator adjustments.

The device is supplied as a monitoring system for use in clinical settings, particularly in anesthesiology, and is authorized under FDA 510(k) clearance K091459. It is classified as a Class II medical device under regulation number 868.1850 and is intended for use in adult patients. The monitor provides real-time data to assist clinicians in assessing and managing patient respiratory status.

Frequently asked questions

What is the Philips NM3 Monitor Model 7900 used for?

The Philips NM3 Monitor Model 7900 is intended for respiratory monitoring in adult patients, providing non-invasive measurement of tidal volume, respiratory rate, and end-tidal CO2, along with capnography, volumetric capnography, airway flow and pressure, and pulse oximetry to assist clinicians in assessing and managing patient respiratory status.

How is the Philips NM3 Monitor Model 7900 supplied and configured for use?

The device is supplied as a monitoring system for use in clinical settings, particularly in anesthesiology, and includes the VentAssist option which delivers graphical data to support ventilator adjustments based on real-time respiratory parameters.

Is the Philips NM3 Monitor Model 7900 reusable or single-use?

The Philips NM3 Monitor Model 7900 is a reusable monitoring system designed for repeated clinical use; it is not a single-use device, as it is intended for ongoing respiratory monitoring in adult patients across multiple sessions.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PHILIPS NM3 MONITOR, MODEL 7900 (K091459) — FDA 510 (k) | Innolitics, Philips NM3 Monitor Model 7900 - Respironics Novametrix | FDA Reference, PDF Respironics NM3 Monitor - documents.philips.com

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Respironics Novametrix, LLC

Sources (1)

  • FDA 510(k) K091459 24 fields · synced Sep 27, 2026