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

    ALP-KII

    K Number: K810008 · Decision Jan 16, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    172
    Registration Numbers
    172
    Same Product Code
    197
    Applicant Total
    4
    Review Days
    11

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    Basic Information

    Device Name
    ALP-KII
    K Number
    K810008
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.1120
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Martin'S Maine Exchange
    Date Received
    January 5, 1981
    Decision Date
    January 16, 1981
    Product Code
    DXQ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DXQ Blood Pressure Cuff

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    Other Clearances by Martin'S Maine Exchange

    K Number Device Name
    K801837 PLASTIC STRIP BANDAGES
    K801839 DISPOSABLE HYPODERMIC NEEDLES
    K801840 SURGICAL BANDAGES/SUNLEEP DX