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FDA 510(k)

MICROCO

K-Number: K950197 · 1996-10-17

ApplicantMicro Direct, Inc.
Decision Date1996-10-17
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICROCO is the device name listed in this FDA 510(k) record. The listed applicant is Micro Direct, Inc.. It received FDA 510(k) clearance on 1996-10-17 under 510(k) number K950197. 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 MICROCO?

MICROCO is a medical device that received FDA 510(k) clearance on 1996-10-17. The listed applicant is Micro Direct, Inc.. The 510(k) number is K950197.

When did MICROCO receive FDA 510(k) clearance?

MICROCO received FDA 510(k) clearance on 1996-10-17, under 510(k) number K950197.

Who is the listed applicant for MICROCO?

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

What is the FDA product code for MICROCO?

The FDA product code for MICROCO is CCJ.

Related Clinical Trials

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Other records listing Micro Direct, 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.

K033688MICRO H2 BREATH MONITORING DEVICE WITH HYDRA SOFTWARE UTILITYK031102MICROLAB SPIROMETERK030586MICROPEAKK973314SPIROSAFE FILTERK965042MICRODL DIARYCARD SPIROMETERK963376MICRO H2

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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

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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