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

    CARDIOVISE ECG INTERPRETATIVE SOFTWARE

    K Number: K001349 · Decision Jul 27, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    48
    Registration Numbers
    48
    Same Product Code
    59
    Applicant Total
    14
    Review Days
    90

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    CARDIOVISE ECG INTERPRETATIVE SOFTWARE
    K Number
    K001349
    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
    April 28, 2000
    Decision Date
    July 27, 2000
    Product Code
    MWJ
    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
    MWJ Electrocardiograph, Ambulatory (Without Analysis)

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (MWJ), ordered by most recent decision date.

    ZywieZ3 Sensor & Adhesive

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HeartBeam AIMIGo(TM) System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASSURE Wearable ECG

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Eclipse MINI Model 98900

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Biotres

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Q Patch

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Inovise Medical, Inc.

    K Number Device Name
    K151433 AUDICOR CA300/CC100 Analyzer with SDB
    K131883 AUDICOR CPAM WITH SDB (ACCELEROMETER BASED)
    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
    Search all 14 clearances from Inovise Medical, Inc. →