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

    DIATHERMY DEVICE-MICROFOCUS

    K Number: K941567 · Decision Apr 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    752

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    Basic Information

    Device Name
    DIATHERMY DEVICE-MICROFOCUS
    K Number
    K941567
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5275
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cheung Laboratories, Inc.
    Date Received
    April 1, 1994
    Decision Date
    April 22, 1996
    Product Code
    IOA
    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
    IOA Diathermy, Microwave, For Use In Applying Therapeutic Deep Heat

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