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

    SYNCHRONIZER #208

    K Number: K810588 · Decision Apr 10, 1981
    View on FDA
    Classifications
    1
    FEI Numbers
    10
    Registration Numbers
    10
    Same Product Code
    3
    Applicant Total
    7
    Review Days
    37

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    Basic Information

    Device Name
    SYNCHRONIZER #208
    K Number
    K810588
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    892.1970
    Medical Specialty
    Radiology
    Decision
    Substantially Equivalent
    Applicant
    Brattle Instrument Corp.
    Date Received
    March 4, 1981
    Decision Date
    April 10, 1981
    Product Code
    IXO
    Advisory Committee
    Radiology
    Review Advisory Committee
    RA
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    IXO Synchronizer, Ecg / Respirator, Radiographic

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