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

    NEOPIP INFANT RESUSCITATOR

    K Number: K072021 · Decision Sep 12, 2007
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    7
    Review Days
    51

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    Basic Information

    Device Name
    NEOPIP INFANT RESUSCITATOR
    K Number
    K072021
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Neoforce Group, Inc.
    Date Received
    July 23, 2007
    Decision Date
    September 12, 2007
    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 Neoforce Group, Inc.

    K Number Device Name
    K110119 PRESSURE MANOMETER
    K103833 NEOPIP PATIENT CIRCUIT WITH PEEP
    K102649 NEOPOP INFANT RESUSCITATOR WITH FLOW METER
    K092085 ISPIRA RESUSCITATION UNIT
    K070416 NEOPEEP NEONATAL RESUSCITATION CIRCUIT WITH PEEP
    K061280 V-2200 INFANT INCUBATOR