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510(k) Data Aggregation

    K Number
    K162768
    Device Name
    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
    Manufacturer
    INTEGRAL PROCESS SAS
    Date Cleared
    2017-08-16

    (320 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRAL PROCESS SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Integral-Process Medical Patient Cable and Leadwire Systems are intended to be used with various electrocardiograph recorders/monitors for both diagnostic and monitoring purposes such as ECG, EKG, SpO2 and Blood Pressure equipment. They are solely intended to be used between the electrode in contact with the patient's skin and the recording/monitoring device. This cabling facilitates the conduction of signals between the patient and the monitoring device. Integral-Process Medical Patient Cable and Leadwire Systems are limited by the Indications for Use of the connected recording/monitoring device.
    Device Description
    Integral-Process Medical Patient Cable and Leadwire Systems are electrical cables interfacing and connecting transducers/sensors/electrodes placed on patients, to monitoring/recording/diagnostic devices/equipment is commonly located in hospitals, doctor's offices, emergency vehicles, as well as in home use. This cabling facilitates the conduction of signals between the patient and the monitoring/recording/diagnostic device. Integral-Process manufactures all type of interfacing transducer and patient cables, as replacement cables and/or as sub-contractor of main brands. These Medical Patient Cable and Leadwire systems are divided into 3 categories: 1) Electrocardiograph (EKG/ECG) cables, 2) SpO2 cables, and 3) IBPT cables.
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    K Number
    K101685
    Device Name
    IP-SET
    Manufacturer
    INTEGRAL PROCESS SAS
    Date Cleared
    2010-07-01

    (15 days)

    Product Code
    DRX
    Regulation Number
    870.2360
    Why did this record match?
    Applicant Name (Manufacturer) :

    INTEGRAL PROCESS SAS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ECG pre-wired harnessed sets of electrodes for short and long term use; for adults, pediatrics and neonates. By design and manufacturing process, the IP-SET® ECG electrodes are of multidisciplinary use, and the unit choice is performed by the Physician, in function of the desired application.
    Device Description
    Set of disposable, single-use, pre-gelled ECG electrodes are regrouped on a flat cable sole or by pair (dual electrodes) and located to ease their positioning on the patient. Electrode number and positioning design vary according to the monitoring/diagnostics application. Pre-gelled (hydro-gel) electrodes are of Ag/AgCl construction with a sensor element area between 10 and 20 mm in diameter, and an adhesive part between 20 and 90 mm in diameter or oblong / rectangular shape. Lead wires are regrouped in a flat cable and are made of copper (radio-opaque) or carbon fiber (radio-translucent). Sets are supplied non-sterile. Each set / harness is packaged in one OPP/PE laminated pouch (sealed foil); 10 to 50 pouches are supplied per box; Shipping cartons contain 12 boxes.
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