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

    MEDICAL, DISPOSABLE BEDDING

    K Number: K850067 · Decision Apr 19, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    573
    Registration Numbers
    573
    Same Product Code
    64
    Applicant Total
    7
    Review Days
    101

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    MEDICAL, DISPOSABLE BEDDING
    K Number
    K850067
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    880.6060
    Medical Specialty
    General Hospital
    Decision
    Substantially Equivalent
    Applicant
    East Texas Lighthouse For the Blind
    Date Received
    January 8, 1985
    Decision Date
    April 19, 1985
    Product Code
    KME
    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
    KME Bedding, Disposable, Medical

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KME), ordered by most recent decision date.

    READY-HEAT BLANKET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    OREX MEDICAL BEDDING

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DISPOSE-A-SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    DOCTOR DOWN --RESCUE WRAP

    FDA 510(k)
    FDA Class 1 ·General Hospital

    AMERICAN BURN SHEET

    FDA 510(k)
    FDA Class 1 ·General Hospital

    FOIL BABY BUNTING

    FDA 510(k)
    FDA Class 1 ·General Hospital
    View all

    Other Clearances by East Texas Lighthouse For the Blind

    K Number Device Name
    K883376 STERILIZATION WRAP TYPE 22,44,77
    K882275 STERILE PACK (PROCEDURAL TRAY/KITS)
    K863733 TOWEL PACK, SURGICAL
    K862062 NONWOVEN SURGICAL DRAPE PACK
    K850811 PAD, PRE-OPERATIVE PREPARATION
    K850016 TOWEL PACK, SURGICAL