BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER

    K Number: K950004 · Decision Oct 24, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    177
    Registration Numbers
    177
    Same Product Code
    574
    Applicant Total
    6
    Review Days
    294

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    Basic Information

    Device Name
    HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
    K Number
    K950004
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2340
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerotel, Ltd.
    Date Received
    January 3, 1995
    Decision Date
    October 24, 1995
    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 Aerotel, Ltd.

    K Number Device Name
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    K961362 AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
    K931020 HEART 1001
    K930314 HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE