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

    THE BIO-TEK UW-II

    K Number: K862932 · Decision Sep 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    44
    Applicant Total
    37
    Review Days
    52

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    Basic Information

    Device Name
    THE BIO-TEK UW-II
    K Number
    K862932
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5290
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Bio-Tek Instruments, Inc.
    Date Received
    August 4, 1986
    Decision Date
    September 25, 1986
    Product Code
    IMJ
    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
    IMJ Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

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