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

    CPR TRACHEOTOMY CARE TRAY

    K Number: K960205 · Decision Aug 27, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    74
    Registration Numbers
    74
    Same Product Code
    127
    Applicant Total
    21
    Review Days
    224

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    Basic Information

    Device Name
    CPR TRACHEOTOMY CARE TRAY
    K Number
    K960205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5800
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Pack Reliability
    Date Received
    January 16, 1996
    Decision Date
    August 27, 1996
    Product Code
    BTO
    Advisory Committee
    Anesthesiology
    Review Advisory Committee
    AN
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    BTO Tube, Tracheostomy (W/Wo Connector)

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    Other Clearances by Custom Pack Reliability

    K Number Device Name
    K960243 CPR C-SECTION DELIVERY PACK
    K960239 CPR D & C TRAY
    K960216 CPR SUCTION CATHETER KIT
    K960211 CPR TOTAL KNEE PACK
    K960210 CPR ORTHO HAND PACK
    K960206 CPR DRESSING CHANGE TRAY
    K960213 CPR TOTAL HIP PACK
    K960209 CPR HEART PACK
    K960214 CPR FOLEY CAHTETER KIT
    K960212 CPR IRRIGATION TRAY
    Search all 21 clearances from Custom Pack Reliability →