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

    CENTURION CARDIAC DETECTOR

    K Number: K832828 · Decision May 9, 1984
    View on FDA
    Classifications
    1
    FEI Numbers
    11
    Registration Numbers
    11
    Same Product Code
    3
    Applicant Total
    3
    Review Days
    264

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    Basic Information

    Device Name
    CENTURION CARDIAC DETECTOR
    K Number
    K832828
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    870.2600
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Clinical Data Instruments, Inc.
    Date Received
    August 19, 1983
    Decision Date
    May 9, 1984
    Product Code
    DRJ
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    N

    Classifications

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

    Product Code Device Name
    DRJ System, Signal Isolation

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    Other Clearances by Clinical Data Instruments, Inc.

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    K842349 AMBULATORY PH RECORDING DEVICE
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