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

    MODEL 1000

    K Number: K844727 · Decision Jul 9, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    217

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    Basic Information

    Device Name
    MODEL 1000
    K Number
    K844727
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent for Some Indications
    Applicant
    Verite
    Date Received
    December 4, 1984
    Decision Date
    July 9, 1985
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    K820651 MODEL 860-1 VERI/PROBE
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    K810496 VERI/PMS MODEL 815
    K791187 MODEL 810 VERI/TGS