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

    CPR GENERAL SURGERY TRAY

    K Number: K960241 · Decision Mar 22, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    3
    Applicant Total
    21
    Review Days
    66

    Basic Information

    Device Name
    CPR GENERAL SURGERY TRAY
    K Number
    K960241
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    892.1560
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Custom Pack Reliability
    Date Received
    January 16, 1996
    Decision Date
    March 22, 1996
    Product Code
    LWI
    Advisory Committee
    Radiology
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    LWI Ultrasound, Sinus

    Similar 510(k) Clearances

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

    SINUSCAN 102/SINUSPRINT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ULTRAMAX/MODEL NUMBER A1

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENTERSCAN

    FDA 510(k)
    FDA Class 2 ·Radiology
    View all

    Other Clearances by Custom Pack Reliability

    K Number Device Name
    K960205 CPR TRACHEOTOMY CARE TRAY
    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
    Search all 21 clearances from Custom Pack Reliability →