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

    CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC

    K Number: K022387 · Decision Sep 19, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    43
    Registration Numbers
    43
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    58

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    Basic Information

    Device Name
    CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC
    K Number
    K022387
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    880.5100
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Craftmatic Organization, Inc.
    Date Received
    July 23, 2002
    Decision Date
    September 19, 2002
    Product Code
    LLI
    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
    LLI Bed, Therapeutic, Ac-Powered, Adjustable Home-Use

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