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

    PULSAR EM

    K Number: K882816 · Decision Apr 27, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    14
    Applicant Total
    6
    Review Days
    293

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    Basic Information

    Device Name
    PULSAR EM
    K Number
    K882816
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Apex Medical, Inc.
    Date Received
    July 8, 1988
    Decision Date
    April 27, 1989
    Product Code
    ILX
    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
    ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat

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