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

    SENSOMAT MUSCLE/TISSUE PH

    K Number: K803260 · Decision Feb 2, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    9
    Applicant Total
    28
    Review Days
    40

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    Basic Information

    Device Name
    SENSOMAT MUSCLE/TISSUE PH
    K Number
    K803260
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1170
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Biochem International, Inc.
    Date Received
    December 24, 1980
    Decision Date
    February 2, 1981
    Product Code
    CBZ
    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
    CBZ Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling

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