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FDA 510(k)

CO-STAT(TM) END TIDAL BREATH ANALYZER

K-Number: K974805 · 1998-03-11

ApplicantNatus Medical, Inc.
Decision Date1998-03-11
Product CodeGHS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CO-STAT(TM) END TIDAL BREATH ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical, Inc.. It received FDA 510(k) clearance on 1998-03-11 under 510(k) number K974805. The device is classified under product code GHS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CO-STAT(TM) END TIDAL BREATH ANALYZER?

CO-STAT(TM) END TIDAL BREATH ANALYZER is a medical device that received FDA 510(k) clearance on 1998-03-11. The listed applicant is Natus Medical, Inc.. The 510(k) number is K974805.

When did CO-STAT(TM) END TIDAL BREATH ANALYZER receive FDA 510(k) clearance?

CO-STAT(TM) END TIDAL BREATH ANALYZER received FDA 510(k) clearance on 1998-03-11, under 510(k) number K974805.

Who is the listed applicant for CO-STAT(TM) END TIDAL BREATH ANALYZER?

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

What is the FDA product code for CO-STAT(TM) END TIDAL BREATH ANALYZER?

The FDA product code for CO-STAT(TM) END TIDAL BREATH ANALYZER is GHS.

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Other records listing Natus Medical, Inc. as applicant

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Related Devices (Code: GHS)

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.

K910827ABL520 BLOOD GAS SYSTEMRadiometer America, Inc.K790943TRISEDTA-BORATE ELECTROPHORESIS FILM AGACorning Medical & ScientificK771263RADIOMHTER OSM-2 HEMOXIMETERThe London Co.K770209ECOLYZER CARBOXIMETERIadec, 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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