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

    FERNO HEALTHCARE RECLINE-A-BATH 2

    K Number: K980033 · Decision Apr 21, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7
    Same Product Code
    72
    Applicant Total
    5
    Review Days
    106

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    Basic Information

    Device Name
    FERNO HEALTHCARE RECLINE-A-BATH 2
    K Number
    K980033
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5100
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ferno-Washington, Inc.
    Date Received
    January 5, 1998
    Decision Date
    April 21, 1998
    Product Code
    ILJ
    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
    ILJ Bath, Hydro-Massage

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