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

    PDB II

    K Number: K830289 · Decision Mar 25, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    51
    Registration Numbers
    51
    Same Product Code
    101
    Applicant Total
    1
    Review Days
    57

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    Basic Information

    Device Name
    PDB II
    K Number
    K830289
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.3760
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    J.A. Gerber Therapeutical, Ltd.
    Date Received
    January 27, 1983
    Decision Date
    March 25, 1983
    Product Code
    INQ
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    INQ Table, Powered

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