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

    BATH TUB TRANSFER CHAIR

    K Number: K842649 · Decision Aug 10, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    74
    Applicant Total
    8
    Review Days
    31

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    Basic Information

    Device Name
    BATH TUB TRANSFER CHAIR
    K Number
    K842649
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.1375
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Guardian Products Co., Inc.
    Date Received
    July 10, 1984
    Decision Date
    August 10, 1984
    Product Code
    IKN
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IKN Electromyograph, Diagnostic

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    Other Clearances by Guardian Products Co., Inc.

    K Number Device Name
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    K842651 COMMODE CHAIR 98200
    K821010 BATHTUB TRANSFER BENCH
    K821009 BATHTUB GRAB BAR
    K790299 FOREARM-CANE
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