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

    NEO-WAVE SYSTEM

    K Number: K810543 · Decision Mar 6, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    27
    Applicant Total
    27
    Review Days
    7

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    Basic Information

    Device Name
    NEO-WAVE SYSTEM
    K Number
    K810543
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5160
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Applicant
    Gaymar Industries, Inc.
    Date Received
    February 27, 1981
    Decision Date
    March 6, 1981
    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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