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

    RESUSCITATION TIMER, MODEL L770-CPR

    K Number: K062080 · Decision Oct 18, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    26
    Review Days
    89

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    Basic Information

    Device Name
    RESUSCITATION TIMER, MODEL L770-CPR
    K Number
    K062080
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    July 21, 2006
    Decision Date
    October 18, 2006
    Product Code
    BTM
    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
    BTM Ventilator, Emergency, Manual (Resuscitator)

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    Other Clearances by Allied Healthcare Products, Inc.

    K Number Device Name
    K131098 EMERGENCY PORTABLE VENTILATOR
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    K090356 EMERGENCY PORTABLE VENTILATOR, MODEL EPV200
    K083507 BATTERY PACK FOR MCV100 AND MCV200 EMERGENCY VENTILATORS
    K083385 MASS CASUALTY VENTILATORS, MODELS: MCV200 AND MCV200-B
    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
    Search all 26 clearances from Allied Healthcare Products, Inc. →