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

    REM-AIR

    K Number: K924686 · Decision Feb 12, 1993
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    27
    Applicant Total
    1
    Review Days
    149

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    Basic Information

    Device Name
    REM-AIR
    K Number
    K924686
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5160
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Mellenair Ent., Inc.
    Date Received
    September 16, 1992
    Decision Date
    February 12, 1993
    Product Code
    INX
    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
    INX Bed, Air Fluidized

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