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

    CARDIO DATA PACERECORDER PR3

    K Number: K853262 · Decision Oct 11, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56
    Same Product Code
    193
    Applicant Total
    6
    Review Days
    67

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    Basic Information

    Device Name
    CARDIO DATA PACERECORDER PR3
    K Number
    K853262
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Applicant
    Cardio Data
    Date Received
    August 5, 1985
    Decision Date
    October 11, 1985
    Product Code
    DSH
    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
    DSH Recorder, Magnetic Tape, Medical

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    Other Clearances by Cardio Data

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    K812149 CARDIO-DATA SYSTEM, #MARK III
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