BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇫🇷 France

    IP-SET

    K Number: K101685 · Decision Jul 1, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    191
    Registration Numbers
    191
    Same Product Code
    328
    Applicant Total
    2
    Review Days
    15

    Basic Information

    Device Name
    IP-SET
    K Number
    K101685
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2360
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    INTEGRAL PROCESS SAS
    Date Received
    June 16, 2010
    Decision Date
    July 1, 2010
    Product Code
    DRX
    Advisory Committee
    Cardiovascular
    Review Advisory Committee
    CV
    Third Party
    Y

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    DRX Electrode, Electrocardiograph

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    Other Clearances by INTEGRAL PROCESS SAS

    K Number Device Name
    K162768 ECG multi leads and IP-SET trunk cable, Monobloc ECG cable, SpO2 sensors and IBP transducers interface cable, ECG leadwire for INTEGRAL PROCESS trunk cables, ECG leadwire for original truk cables