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

    MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B

    K Number: K083385 · Decision May 14, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    26
    Review Days
    178

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    Basic Information

    Device Name
    MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
    K Number
    K083385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    November 17, 2008
    Decision Date
    May 14, 2009
    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 Allied Healthcare Products, Inc.

    K Number Device Name
    K131098 EMERGENCY PORTABLE VENTILATOR
    K132021 AHP 300, EMERGENCY PORTABLE VENTILATOR
    K090356 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    K083507 BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    K080063 MASS CASUALTY VENTILATOR, MODEL MCV100
    K072214 PORTABLE VENTILATOR, MODEL EPV-100
    K073171 RESUSCITATION TIMER, MODEL L770-CPR
    K070636 AUTOVENT 4000 WITH CPAP
    K070120 AUTOVENT MODEL 4000
    K062080 RESUSCITATION TIMER, MODEL L770-CPR
    Search all 26 clearances from Allied Healthcare Products, Inc. →