BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    IMMOBILIZING VACUUM MATRESS (IVM)

    K Number: K863511 · Decision Sep 25, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    124
    Registration Numbers
    124
    Same Product Code
    38
    Applicant Total
    1
    Review Days
    16

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    Basic Information

    Device Name
    IMMOBILIZING VACUUM MATRESS (IVM)
    K Number
    K863511
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6900
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    Omnium Services Partners, Inc.
    Date Received
    September 9, 1986
    Decision Date
    September 25, 1986
    Product Code
    FPP
    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
    FPP Stretcher, Hand-Carried

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