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

    MODEL 5460 + 5480 POP-OFF VALVES

    K Number: K802591 · Decision Nov 12, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    33
    Registration Numbers
    33
    Same Product Code
    187
    Applicant Total
    2
    Review Days
    22

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    Basic Information

    Device Name
    MODEL 5460 + 5480 POP-OFF VALVES
    K Number
    K802591
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.5160
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    G. Dundas Co.
    Date Received
    October 21, 1980
    Decision Date
    November 12, 1980
    Product Code
    BSZ
    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
    BSZ Gas-Machine, Anesthesia

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    Other Clearances by G. Dundas Co.

    K Number Device Name
    K963601 MODEL 1920 WASTE GAS SCAVENGER