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FDA 510(k)

PHILIPS NM3 MONITOR, MODEL 7900

K-Number: K091459 · 2009-07-28

ApplicantRespironics Novametrix, LLC
Decision Date2009-07-28
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PHILIPS NM3 MONITOR, MODEL 7900 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Novametrix, LLC. It received FDA 510(k) clearance on 2009-07-28 under 510(k) number K091459. The device is classified under product code BZK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHILIPS NM3 MONITOR, MODEL 7900?

PHILIPS NM3 MONITOR, MODEL 7900 is a medical device that received FDA 510(k) clearance on 2009-07-28. The listed applicant is Respironics Novametrix, LLC. The 510(k) number is K091459.

When did PHILIPS NM3 MONITOR, MODEL 7900 receive FDA 510(k) clearance?

PHILIPS NM3 MONITOR, MODEL 7900 received FDA 510(k) clearance on 2009-07-28, under 510(k) number K091459.

Who is the listed applicant for PHILIPS NM3 MONITOR, MODEL 7900?

The FDA 510(k) record lists Respironics Novametrix, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PHILIPS NM3 MONITOR, MODEL 7900?

The FDA product code for PHILIPS NM3 MONITOR, MODEL 7900 is BZK.

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Other records listing Respironics Novametrix, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K103578PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSISTK080652MERCURY VCO2 MODULE WITH CAPNOSTAT 5K053174LOFLO C5 CO2 SENSOR

Related Devices (Code: BZK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260226ElintMAX Respiratory Monitor (ElintMAX Monitor A1)Amptron Medical, Inc.K192584BEACON Caresystem Model 00002144Mermaid Care A/SK192595ExSpiron 2XiRespiratory MotionK180788Gas Module 3Shenzhen Mindray Bio-Medical Electronics Co., Ltd.K173181ExSpiron 1XiRespiratory Motion, Inc.K162131ExSpiron 1XiRespiratory Motion, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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