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

    SENSOMAT

    K Number: K771722 · Decision Sep 26, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    14
    Applicant Total
    28
    Review Days
    13

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    Basic Information

    Device Name
    SENSOMAT
    K Number
    K771722
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1150
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biochem International, Inc.
    Date Received
    September 13, 1977
    Decision Date
    September 26, 1977
    Product Code
    CCC
    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
    CCC Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling

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