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FDA 510(k)

CAPNOMED 100 STAND-ALONE ETCO2 MODULE

K-Number: K920915 · 1993-03-23

ApplicantMennen Medical, Inc.
Decision Date1993-03-23
Product CodeCCK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CAPNOMED 100 STAND-ALONE ETCO2 MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Mennen Medical, Inc.. It received FDA 510(k) clearance on 1993-03-23 under 510(k) number K920915. 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 CAPNOMED 100 STAND-ALONE ETCO2 MODULE?

CAPNOMED 100 STAND-ALONE ETCO2 MODULE is a medical device that received FDA 510(k) clearance on 1993-03-23. The listed applicant is Mennen Medical, Inc.. The 510(k) number is K920915.

When did CAPNOMED 100 STAND-ALONE ETCO2 MODULE receive FDA 510(k) clearance?

CAPNOMED 100 STAND-ALONE ETCO2 MODULE received FDA 510(k) clearance on 1993-03-23, under 510(k) number K920915.

Who is the listed applicant for CAPNOMED 100 STAND-ALONE ETCO2 MODULE?

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

What is the FDA product code for CAPNOMED 100 STAND-ALONE ETCO2 MODULE?

The FDA product code for CAPNOMED 100 STAND-ALONE ETCO2 MODULE is CCK.

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Other records listing Mennen Medical, Inc. 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.

K030722ENVOY PATIENT MONITORK983864ETCO2 VITAL SIGNS MODULEK991775MODIFICATION TO COMPUTERIZED CATHETERIZATION LABORATORY - HORIZON 9000 WSK982697MODIFICATION TO ENSEMBLE CENTRAL STATION MONITORK974510ENVOY PATIENT MONITORK970358ENSEMBLE CENTRAL STATION MONITOR

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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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