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FDA 510(k)

CAPNOSTAT 5

K-Number: K042601 · 2004-11-19

ApplicantRespironics Novametrix, Inc.
Decision Date2004-11-19
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOSTAT 5 is the device name listed in this FDA 510(k) record. The listed applicant is Respironics Novametrix, Inc.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042601. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPNOSTAT 5?

CAPNOSTAT 5 is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Respironics Novametrix, Inc.. The 510(k) number is K042601.

When did CAPNOSTAT 5 receive FDA 510(k) clearance?

CAPNOSTAT 5 received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042601.

Who is the listed applicant for CAPNOSTAT 5?

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

What is the FDA product code for CAPNOSTAT 5?

The FDA product code for CAPNOSTAT 5 is CCK.

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Other records listing Respironics Novametrix, Inc. as applicant

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Related Devices (Code: CCK)

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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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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