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FDA 510(k)

STATCO2METER, MODEL 10-55372

K-Number: K031814 · 2003-08-14

ApplicantMercury Medical
Decision Date2003-08-14
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STATCO2METER, MODEL 10-55372 is the device name listed in this FDA 510(k) record. The listed applicant is Mercury Medical. It received FDA 510(k) clearance on 2003-08-14 under 510(k) number K031814. 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 STATCO2METER, MODEL 10-55372?

STATCO2METER, MODEL 10-55372 is a medical device that received FDA 510(k) clearance on 2003-08-14. The listed applicant is Mercury Medical. The 510(k) number is K031814.

When did STATCO2METER, MODEL 10-55372 receive FDA 510(k) clearance?

STATCO2METER, MODEL 10-55372 received FDA 510(k) clearance on 2003-08-14, under 510(k) number K031814.

Who is the listed applicant for STATCO2METER, MODEL 10-55372?

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 STATCO2METER, MODEL 10-55372?

The FDA product code for STATCO2METER, MODEL 10-55372 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 MONOMETERK031411MINI STATCO2 CO2 DETECTOR, MODEL 10-55371K021576MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370K001714MERCURY 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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