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

    PARAMEDIC O2 KIT

    K Number: K780168 · Decision Apr 18, 1978
    View on FDA
    Classifications
    1
    FEI Numbers
    47
    Registration Numbers
    47
    Same Product Code
    99
    Applicant Total
    1
    Review Days
    75

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    Basic Information

    Device Name
    PARAMEDIC O2 KIT
    K Number
    K780168
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Pohlmann Rescue Products, Inc.
    Date Received
    February 2, 1978
    Decision Date
    April 18, 1978
    Product Code
    BTL
    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
    BTL Ventilator, Emergency, Powered (Resuscitator)

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