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

    POSEY BED

    K Number: K113355 · Decision May 2, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    2
    Applicant Total
    13
    Review Days
    170

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    Basic Information

    Device Name
    POSEY BED
    K Number
    K113355
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6760
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    J. T. Posey Co.
    Date Received
    November 14, 2011
    Decision Date
    May 2, 2012
    Product Code
    OYS
    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
    OYS Patient Bed With Canopy/Restraints

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    Other Clearances by J. T. Posey Co.

    K Number Device Name
    K113357 POSEY BED
    K103817 POSEY BED
    K963414 MULTIPLE BELTS
    K963410 POSEY STRAIGHT JACKETS
    K963442 JACKETS AND VESTS
    K963436 RESTRAINT ACCESSORIES
    K963439 PEDIATRIC LIMB HOLDERS
    K963437 PELVIC HOLDERS
    K963411 POSEY LAPTOP TRAYS
    K963413 MULTIPLE LIMB HOLDERS
    Search all 13 clearances from J. T. Posey Co. →