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

    EMERGENCY OXYGEN RESUSCITATOR

    K Number: K771299 · Decision Aug 4, 1977
    View on FDA
    Classifications
    1
    FEI Numbers
    45
    Registration Numbers
    45
    Same Product Code
    99
    Applicant Total
    6
    Review Days
    21

    Basic Information

    Device Name
    EMERGENCY OXYGEN RESUSCITATOR
    K Number
    K771299
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5925
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    FRASER SWEATMAN, INC.
    Date Received
    July 14, 1977
    Decision Date
    August 4, 1977
    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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    Other Clearances by FRASER SWEATMAN, INC.

    K Number Device Name
    K770911 MEDISHIELD JORDON LIFTING FRAME
    K770910 MEDISHIELD CERVICAL COLLAR
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    K760766 PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER
    K760076 ABSORBER, ANESTHESIA CIRCLE SYS, CO2