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FDA 510(k)

MERCURY VCO2 MODULE WITH CAPNOSTAT 5

K-Number: K080652 · 2008-06-20

ApplicantRespironics Novametrix, LLC
Decision Date2008-06-20
Product CodeBZK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MERCURY VCO2 MODULE WITH CAPNOSTAT 5 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 2008-06-20 under 510(k) number K080652. 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 MERCURY VCO2 MODULE WITH CAPNOSTAT 5?

MERCURY VCO2 MODULE WITH CAPNOSTAT 5 is a medical device that received FDA 510(k) clearance on 2008-06-20. The listed applicant is Respironics Novametrix, LLC. The 510(k) number is K080652.

When did MERCURY VCO2 MODULE WITH CAPNOSTAT 5 receive FDA 510(k) clearance?

MERCURY VCO2 MODULE WITH CAPNOSTAT 5 received FDA 510(k) clearance on 2008-06-20, under 510(k) number K080652.

Who is the listed applicant for MERCURY VCO2 MODULE WITH CAPNOSTAT 5?

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 MERCURY VCO2 MODULE WITH CAPNOSTAT 5?

The FDA product code for MERCURY VCO2 MODULE WITH CAPNOSTAT 5 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.

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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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