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

    AIR-SHIELDS RESUSCITATORS

    K Number: K792118 · Decision Nov 13, 1979
    View on FDA
    Classifications
    1
    FEI Numbers
    75
    Registration Numbers
    75
    Same Product Code
    208
    Applicant Total
    19
    Review Days
    18

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    Basic Information

    Device Name
    AIR-SHIELDS RESUSCITATORS
    K Number
    K792118
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5915
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Narco Air-Shields
    Date Received
    October 26, 1979
    Decision Date
    November 13, 1979
    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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    K802800 NARCO AIR-SHEILDS SYS. 100 MONITOR SYS
    K802126 ISOLETTE INCUBATOR C-100
    K792592 AMBU UNIVERSAL SUCTION PUMP
    K792499 AMBU PAEDI ANAESTHESIA SYSTEM
    K792117 AIR-SHIELDS HEART RATE MONITOR
    K790552 AS7 & AS8 MONITORS
    K790551 TRANSPORT INCUBATOR
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