BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VITALOGRAPH - BREATHCO MONITOR

    K Number: K902113 · Decision Oct 26, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    168

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    Basic Information

    Device Name
    VITALOGRAPH - BREATHCO MONITOR
    K Number
    K902113
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Mcneill Intl., Inc.
    Date Received
    May 11, 1990
    Decision Date
    October 26, 1990
    Product Code
    CCJ
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    CCJ Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase

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