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

    BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK

    K Number: K952689 · Decision Jul 11, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    158
    Registration Numbers
    158
    Same Product Code
    50
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    BRIGAM MEDICAL DISPOSABLE ANESTHESIA/RESPIRATORY FACE MASK
    K Number
    K952689
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.5550
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Owens-Brigam Medical Co.
    Date Received
    June 12, 1995
    Decision Date
    July 11, 1995
    Product Code
    BSJ
    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
    BSJ Mask, Gas, Anesthetic

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    Other Clearances by Owens-Brigam Medical Co.

    K Number Device Name
    K963848 MANUAL RESUSCITATOR