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

    HYPER-INFLATION BAG

    K Number: K942571 · Decision Jun 10, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    9
    Applicant Total
    17
    Review Days
    10

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    Basic Information

    Device Name
    HYPER-INFLATION BAG
    K Number
    K942571
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5905
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Med-Plastics Intl., Inc.
    Date Received
    May 31, 1994
    Decision Date
    June 10, 1994
    Product Code
    NHK
    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
    NHK Resuscitator, Manual, Non Self-Inflating

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    Other Clearances by Med-Plastics Intl., Inc.

    K Number Device Name
    K946209 DISPODABLE HEAT & MOISTURE EXCHANGER AND FILTER/HME
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    K942572 VOLUME VENTILATOR
    K942568 ADULT ANESTHESIA BREATHING CIRCUIT
    K942567 MASS SPECTROMETRY MONITORING LINES AND CONNECTORS
    K932575 ADULT TEMPERATURE MONITORING ANESTHESIA CIRCUITS
    K932578 ADULT GAS SAMPLING CIRCUITS
    K932576 PEDIATRIC TEMPERATURE MONITORING CIRCUITS
    K932577 PEDIATRIC GAS SAMPLING
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