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

    FULL/SEMI ELECTRIC HOME CARE BED

    K Number: K925534 · Decision May 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    228
    Registration Numbers
    228
    Same Product Code
    69
    Applicant Total
    2
    Review Days
    191

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    Basic Information

    Device Name
    FULL/SEMI ELECTRIC HOME CARE BED
    K Number
    K925534
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Ivacare Corp.
    Date Received
    November 2, 1992
    Decision Date
    May 12, 1993
    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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