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

    SARA

    K Number: K810585 · Decision Mar 24, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    54
    Same Product Code
    16
    Applicant Total
    26
    Review Days
    20

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    Basic Information

    Device Name
    SARA
    K Number
    K810585
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    868.1620
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Allied Healthcare Products, Inc.
    Date Received
    March 4, 1981
    Decision Date
    March 24, 1981
    Product Code
    CBS
    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
    CBS Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)

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