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

    AUDICOR UPGRADE SYSTEM

    K Number: K032145 · Decision Oct 31, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    14
    Review Days
    109

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    Basic Information

    Device Name
    AUDICOR UPGRADE SYSTEM
    K Number
    K032145
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inovise Medical, Inc.
    Date Received
    July 14, 2003
    Decision Date
    October 31, 2003
    Product Code
    DPS
    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
    DPS Electrocardiograph

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    Other Clearances by Inovise Medical, Inc.

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    K130660 AUDICOR CPAM WITH SDB (SINGLE SENSOR)
    K120462 AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
    K110569 AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
    K103516 AUDICOR SENSOR-ADAPTER MODEL AUDICOR SENSOR-ADAPTER 4.0
    K080602 AUDICOR SENSOR, MODELS: 2.0, 3.0
    K073545 AUDICOR, HEMO AMBULATORY MONITOR
    K070136 AUDICOR 200 SYSTEM, MODELS 200D AND 200S
    K051450 EXTENDED MEASUREMENTS SYSTEM
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