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

    VORTRAN APM-Plus

    K Number: K182292 · Decision Sep 18, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    55
    Registration Numbers
    55
    Same Product Code
    77
    Applicant Total
    28
    Review Days
    391

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    Basic Information

    Device Name
    VORTRAN APM-Plus
    K Number
    K182292
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.2600
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vortran Medical Technology 1, Inc.
    Date Received
    August 23, 2018
    Decision Date
    September 18, 2019
    Product Code
    CAP
    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
    CAP Monitor, Airway Pressure (Includes Gauge And/Or Alarm)

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    Other Clearances by Vortran Medical Technology 1, Inc.

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    K153733 VORTRAN Manometer
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    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
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