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

    K.P.R. (KING PERSONAL RESUSCITATOR)

    K Number: K943402 · Decision Aug 19, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    18
    Review Days
    36

    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
    K.P.R. (KING PERSONAL RESUSCITATOR)
    K Number
    K943402
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    King Systems Corp.
    Date Received
    July 14, 1994
    Decision Date
    August 19, 1994
    Product Code
    CBP
    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
    CBP Valve, Non-Rebreathing

    Similar 510(k) Clearances

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

    QualityFlow O2 Series (QualityFLOW O2); QualityFlow O2 Series (QualityFLOW O2 MTV)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    F&P Optiflow Flow Diverter

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Altech® Exhalation Valve (Single Limb and Dual Limb)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CPR Face Shield

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    OJR215 Pressure Relief Manifold

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)

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

    Other Clearances by King Systems Corp.

    K Number Device Name
    K033189 KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 303, KLT 304 AND KLT 305
    K033186 KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205
    K021634 KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105
    K012485 MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMANCE ANGLED; MS-142 ALL-ROUND/HME ENHANCE
    K010040 SLEEVED FILTER
    K990614 HME-BOOSTER
    K983817 BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F)
    K973797 BREATHING CIRCUIT BACTERIAL FILTER
    K953513 XENON CIRCUIT
    K951093 KAB SYSTEM
    Search all 18 clearances from King Systems Corp. →