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

    HEART 400 ECG TRANSMITTER

    K Number: K953762 · Decision Jul 18, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    6
    Review Days
    342

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    Basic Information

    Device Name
    HEART 400 ECG TRANSMITTER
    K Number
    K953762
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerotel, Ltd.
    Date Received
    August 11, 1995
    Decision Date
    July 18, 1996
    Product Code
    DXH
    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
    DXH Transmitters And Receivers, Electrocardiograph, Telephone

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    Other Clearances by Aerotel, Ltd.

    K Number Device Name
    K980144 HEARTVIEW P12/8 ELECTROCARDIOGRAPH RECORDER AND TRANSMITTER
    K961362 AEROTEL TELELINK ECG TELEPHONIC RECEIVING INTERFACE
    K950004 HEARTVIEW(TM) 12-LEAD ELECTROCARDIOGRAPH RECORDER/TRANSMITTER
    K931020 HEART 1001
    K930314 HEARTLINE TRANSTELEPHONIC ECG RECEIVING CONSOLE