BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

    Y2000 POCKET RESCUE

    K Number: K010191 · Decision Mar 14, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    70
    Registration Numbers
    70
    Same Product Code
    102
    Applicant Total
    6
    Review Days
    51

    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
    Y2000 POCKET RESCUE
    K Number
    K010191
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5870
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Cheen Houng Ent. Co. , Ltd.
    Date Received
    January 22, 2001
    Decision Date
    March 14, 2001
    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 Cheen Houng Ent. Co. , Ltd.

    K Number Device Name
    K121587 BREATH SHAKE
    K021390 PMX COMPACT RESUCITATOR
    K003927 Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
    K981415 0-20 CM H20 PEEP VALVE
    K970688 POCKET RESCUE