BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    DISPOSABLE RESCUE BREATHING DEVICE

    K Number: K861054 · Decision Apr 9, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    229
    Registration Numbers
    229
    Same Product Code
    56
    Applicant Total
    18
    Review Days
    21

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    Basic Information

    Device Name
    DISPOSABLE RESCUE BREATHING DEVICE
    K Number
    K861054
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5110
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    B & F Medical Products, Inc.
    Date Received
    March 19, 1986
    Decision Date
    April 9, 1986
    Product Code
    CAE
    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
    CAE Airway, Oropharyngeal, Anesthesiology

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    K802644 EMERG. OXYGEN KIT #65350 & #65399 CASE
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