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

    FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR

    K Number: K880394 · Decision Feb 29, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    10
    Review Days
    31

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    Basic Information

    Device Name
    FIRST RESPONSE PEDIATRIC EMERGENCY RESUSCITATOR
    K Number
    K880394
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Intertech/Ohio
    Date Received
    January 29, 1988
    Decision Date
    February 29, 1988
    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 Intertech/Ohio

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    K884526 ADULT RESUSCITATOR WITH MASK AND FILTER
    K882204 RESUSCITATOR VALVE ASSEMBLY W/FILTER
    K863033 PATIENT GAS SAMPLING KIT/5STAND ALONE VERSIONS
    K862020 HEAT/MOISTURE EXCHANGER, HME, W/INTEGRAL FILTER
    K860650 90 DEGREE ELBOW & STRAIGHT CONNECTOR
    K861056 STRAIGHT ADAPT W/TEMP SENSING PORT/CLOSURE PLUG