BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MASS SPECTROMETER-MEDSPECT II

    K Number: K810938 · Decision Apr 23, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18
    Same Product Code
    9
    Applicant Total
    26
    Review Days
    16

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    Basic Information

    Device Name
    MASS SPECTROMETER-MEDSPECT II
    K Number
    K810938
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    862.2860
    Medical Specialty
    Clinical Chemistry
    Decision
    Substantially Equivalent
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    April 7, 1981
    Decision Date
    April 23, 1981
    Product Code
    DOP
    Advisory Committee
    Clinical Chemistry
    Review Advisory Committee
    TX
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DOP Mass Spectrometer, Clinical Use

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