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

    JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL

    K Number: K951735 · Decision Aug 18, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    126

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    Basic Information

    Device Name
    JOERNS HEALTHCARE, INC. FULL LENGTH TELESCOPING RAIL
    K Number
    K951735
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Joerns Healthcare, Inc.
    Date Received
    April 14, 1995
    Decision Date
    August 18, 1995
    Product Code
    FNL
    Advisory Committee
    General Hospital
    Review Advisory Committee
    HO
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FNL Bed, Ac-Powered Adjustable Hospital

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    Other Clearances by Joerns Healthcare, Inc.

    K Number Device Name
    K964926 BATH AIR SPA FIXED HEIGHT HYDRAULIC OPERATED/ADJUSTABLE HEIGHT HYDRAULIC/FIXED HEIGHT ELECTRIC RECLINING/HEIGHT ELECTRIC