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FDA 510(k)

VITALOGRAPH-BREATHCO MONITOR

K-Number: K892524 · 1989-05-05

ApplicantVitalograph , Ltd.
Decision Date1989-05-05
Product CodeCCJ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VITALOGRAPH-BREATHCO MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Vitalograph , Ltd.. It received FDA 510(k) clearance on 1989-05-05 under 510(k) number K892524. 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 VITALOGRAPH-BREATHCO MONITOR?

VITALOGRAPH-BREATHCO MONITOR is a medical device that received FDA 510(k) clearance on 1989-05-05. The listed applicant is Vitalograph , Ltd.. The 510(k) number is K892524.

When did VITALOGRAPH-BREATHCO MONITOR receive FDA 510(k) clearance?

VITALOGRAPH-BREATHCO MONITOR received FDA 510(k) clearance on 1989-05-05, under 510(k) number K892524.

Who is the listed applicant for VITALOGRAPH-BREATHCO MONITOR?

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

What is the FDA product code for VITALOGRAPH-BREATHCO MONITOR?

The FDA product code for VITALOGRAPH-BREATHCO MONITOR is CCJ.

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Other records listing Vitalograph , Ltd. 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.

K253293VitaloJAK Clinic (Model 7100)K950854VITALOGRAPH 2110 SOFTWARE INTERFACEK925085ESCORT SPIROMETERK930085VITALOGRAPH DATA STORAGE SPIROMETERK912412VITALOGRAPH SPIROTRAC IIIK893665AEROSOL INHALATION MONITOR

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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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