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

    OMRON PULSE STIMULATOR MODEL HV-F05

    K Number: K902255 · Decision Oct 31, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    10
    Review Days
    163

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    Basic Information

    Device Name
    OMRON PULSE STIMULATOR MODEL HV-F05
    K Number
    K902255
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Omron Electronics, Inc.
    Date Received
    May 21, 1990
    Decision Date
    October 31, 1990
    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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