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FDA 510(k)

COSENSE

K-Number: K121768 · 2012-10-31

ApplicantCapnia, Inc.
Decision Date2012-10-31
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

COSENSE is the device name listed in this FDA 510(k) record. The listed applicant is Capnia, Inc.. It received FDA 510(k) clearance on 2012-10-31 under 510(k) number K121768. The device is classified under product code CCJ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COSENSE?

COSENSE is a medical device that received FDA 510(k) clearance on 2012-10-31. The listed applicant is Capnia, Inc.. The 510(k) number is K121768.

When did COSENSE receive FDA 510(k) clearance?

COSENSE received FDA 510(k) clearance on 2012-10-31, under 510(k) number K121768.

Who is the listed applicant for COSENSE?

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

What is the FDA product code for COSENSE?

The FDA product code for COSENSE is CCJ.

Related Clinical Trials

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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Other records listing Capnia, 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.

K253119CoSense ETCO Monitor

Related Devices (Code: CCJ)

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.

K253119CoSense ETCO MonitorCapnia, Inc.K211918iCOquit® Smokerlyzer®Bedfont Scientific, Ltd.K201206Pivot Breath SensorCarrot, Inc.K173238ToxCOBedfont Scientific, Ltd.K171129CO Check Pro, CO ScreenMD Diagnostics LimitedK171408Carbon Monoxide Breath Sensor System (COBSS)Carrot Sense, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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