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

    FRASER SWEATMAN'S DOUBLE MASK

    K Number: K761140 · Decision Dec 9, 1976
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14
    Same Product Code
    42
    Applicant Total
    6
    Review Days
    13

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    Basic Information

    Device Name
    FRASER SWEATMAN'S DOUBLE MASK
    K Number
    K761140
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5430
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Fraser Sweatman, Inc.
    Date Received
    November 26, 1976
    Decision Date
    December 9, 1976
    Product Code
    CBN
    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
    CBN Apparatus, Gas-Scavenging

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