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

    HEART 2006

    K Number: K032736 · Decision Oct 3, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    80
    Registration Numbers
    80
    Same Product Code
    296
    Applicant Total
    7
    Review Days
    29

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    Basic Information

    Device Name
    HEART 2006
    K Number
    K032736
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    870.2920
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Aerotel Medical Systems (1998) , Ltd.
    Date Received
    September 4, 2003
    Decision Date
    October 3, 2003
    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 Medical Systems (1998) , Ltd.

    K Number Device Name
    K030825 MPM-NET
    K023418 HEARTONE EVENT RECORDER AND TRANSMITTER
    K022073 HEARTLINE RECEIVING STATION
    K021447 TELE-CLINIQ DATA TRANSMISSION SYSTEM BLOOD PRESSURE MEASUREMENT SYSTEM
    K000775 HEART 2005
    K983717 BP-TEL TRANS-TELEPHONIC BLOOD PRESSURE MEASUREMENT SYSTEM