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

    VORTRAN GO2VENT

    K Number: K162968 · Decision Apr 10, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    28
    Review Days
    168

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    Basic Information

    Device Name
    VORTRAN GO2VENT
    K Number
    K162968
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortran Medical Technology 1, Inc.
    Date Received
    October 24, 2016
    Decision Date
    April 10, 2017
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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    Other Clearances by Vortran Medical Technology 1, Inc.

    K Number Device Name
    K202219 VORTRAN GO2VENT with PEEP Valve
    K182292 VORTRAN APM-Plus
    K173914 VORTRAN Cuff Inflator (VCI)
    K153733 VORTRAN Manometer
    K103639 VORTRAN AIRWAY PRESSURE MONITOR (VAPM)-ADULT, VORTRAN AIRWAY PRESSURE MONITOR (VAPM)- PEDIATRIC
    K073261 VAR MONITOR
    K041473 VAR-PLUS (VORTRAN AUTOMATIC RESUSCITATOR), MODEL PCM
    K003684 PERCUSSIVENEB, MODEL PN-2001
    K001430 RESPIRTECH PRO-O2C, MODEL 2200 AND RESPIRTECH PRO, MODEL 2000
    K982016 PIPER IPPB MODEL 2055
    Search all 28 clearances from Vortran Medical Technology 1, Inc. →