BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SITZ BATH, SINGLE PATIENT USE #8100

    K Number: K831762 · Decision Jun 24, 1983
    View on FDA
    Classifications
    1
    FEI Numbers
    49
    Registration Numbers
    49
    Same Product Code
    6
    Applicant Total
    2
    Review Days
    23

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    Basic Information

    Device Name
    SITZ BATH, SINGLE PATIENT USE #8100
    K Number
    K831762
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    890.5125
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Lsl Industries, Inc.
    Date Received
    June 1, 1983
    Decision Date
    June 24, 1983
    Product Code
    KTC
    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
    KTC Bath, Sitz, Nonpowered

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    Other Clearances by Lsl Industries, Inc.

    K Number Device Name
    K882714 URINARY DRAIN BAG, LSL CAT. NO. 1425 AND 1450