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FDA 510(k)

MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370

K-Number: K021576 · 2002-11-04

ApplicantMercury Medical
Decision Date2002-11-04
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Medical. It received FDA 510(k) clearance on 2002-11-04 under 510(k) number K021576. 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 MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370?

MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 is a medical device that received FDA 510(k) clearance on 2002-11-04. The listed applicant is Mercury Medical. The 510(k) number is K021576.

When did MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 receive FDA 510(k) clearance?

MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 received FDA 510(k) clearance on 2002-11-04, under 510(k) number K021576.

Who is the listed applicant for MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370?

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

What is the FDA product code for MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370?

The FDA product code for MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 is CCK.

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Other records listing Mercury Medical 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.

K090710MERCURY CPAPK083056NEO-STAT CO2 <KGK032593MERCURY MEDICAL NEGATIVE INSPIRATORY FORCE (NIF) DISPOSABLE MONOMETERK031814STATCO2METER, MODEL 10-55372K031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371K001714MERCURY MEDICAL HYPERINFLATION BAG SYSTEM, MODEL 83-900-0149

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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.

K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden CorporationK261633VisuBreathAffirm Medical Technologies II, LLCK253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLCK250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd.K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden CorporationK2512160184 CO2 Sampling line; 0184T CO2 Sampling line; 0139 CO2 Sampling line; 0182 CO2 Sampling lineBarbaras Development, 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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