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

    AUDICOR CPAM WITH SDB (SINGLE SENSOR)

    K Number: K130660 · Decision Oct 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    31
    Registration Numbers
    31
    Same Product Code
    31
    Applicant Total
    14
    Review Days
    213

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    Basic Information

    Device Name
    AUDICOR CPAM WITH SDB (SINGLE SENSOR)
    K Number
    K130660
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2800
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Inovise Medical, Inc.
    Date Received
    March 12, 2013
    Decision Date
    October 11, 2013
    Product Code
    MLO
    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
    MLO Electrocardiograph, Ambulatory, With Analysis Algorithm

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    Other Clearances by Inovise Medical, Inc.

    K Number Device Name
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    K120462 AUDICOR CPAM WITH SDB (CARDIOPULMONARY AMBULATORY MONITOR WITH SLEEP DISORDERED BREATHING DETECTION)
    K110569 AUDICOR CPAM (CARDIOPULMONARY AMBULATORY MONITOR)
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    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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