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FDA 510(k)

PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST

K-Number: K103578 · 2011-06-02

ApplicantRespironics Novametrix, LLC
Decision Date2011-06-02
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST 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 2011-06-02 under 510(k) number K103578. 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 RESPIRATORY MONITOR WITH VENTASSIST?

PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST is a medical device that received FDA 510(k) clearance on 2011-06-02. The listed applicant is Respironics Novametrix, LLC. The 510(k) number is K103578.

When did PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST receive FDA 510(k) clearance?

PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST received FDA 510(k) clearance on 2011-06-02, under 510(k) number K103578.

Who is the listed applicant for PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST?

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 RESPIRATORY MONITOR WITH VENTASSIST?

The FDA product code for PHILIPS NM3 RESPIRATORY MONITOR WITH VENTASSIST 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.

K091459PHILIPS NM3 MONITOR, MODEL 7900K080652MERCURY 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

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

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