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

    POLY G PHYSIOLOGICAL DATA RECORDER

    K Number: K897107 · Decision Mar 12, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    1
    Applicant Total
    14
    Review Days
    81

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    Basic Information

    Device Name
    POLY G PHYSIOLOGICAL DATA RECORDER
    K Number
    K897107
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    868.2900
    Medical Specialty
    Anesthesiology
    Decision
    Substantially Equivalent
    Applicant
    Cns, Inc.
    Date Received
    December 21, 1989
    Decision Date
    March 12, 1990
    Product Code
    BXO
    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
    BXO Transducer, Gas Pressure

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