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510(k) Data Aggregation

    K Number
    K213730
    Device Name
    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI
    Manufacturer
    Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o.
    Date Cleared
    2022-04-21

    (146 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    Mesi, Development of Medical Devices, Ltd.; Mesi d

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K201046
    Device Name
    Automated ankle brachial pressure index measuring device, MESI mTABLET system
    Manufacturer
    Mesi D.O.O.; Mesi, Development of medical devices, Ltd.
    Date Cleared
    2020-12-11

    (234 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ; Mesi, Development of medical devices, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MESI mTABLET ABI is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). MESI mTABLET ABI is intended for the rapid measurement of ankle-brachial pressure index (AB) and pulse volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy. MESI mTABLET ABI can be used on patients with unilateral lower limb amputation. The MESI mTABLET ABI is intended to be used to spot-check patients. The MESI mTABLET ABI provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.
    Device Description
    MESI mTABLET ABI is a medical device comprised out of three parts. Diagnostic modules with a tubeless cuff (ABISYS) that is attached to a patient upper arms and ankles, a medical grade tablet used to display the measurement (MTABSYSW) and a charging station (CS4SYS). It is used in a professional clinical environment by trained medical experts for diaqnostic and screening purposes. MESI mTABLET ABI is a device used for screening of Peripheral Arterial Disease (PAD). The measurement is performed non-invasively by measuring blood pressure in the brachial artery and pressures in the foot arteries (dorsalis pedis and the posterior tibial artery). After the blood pressures have been measured the MESI mTABLET ABI calculates the ration between higher of the two arm values and both ankles.
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    K Number
    K172655
    Device Name
    Automated ankle brachial pressure index measuring device
    Manufacturer
    Mesi D.O.O.; Mesi, Development of medical devices, Ltd.
    Date Cleared
    2018-01-11

    (128 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    ; Mesi, Development of medical devices, Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ABPI MD system is indicated for use on adult subjects at risk of having or developing peripheral arterial disease (PAD). The ABPI MD system is intended for the rapid measurement of ankle-brachial pressure index (ABPI), or ankle-brachial index (ABI) and pulse volume recording (PVR)/volume plethysmography in adults. It is suitable for use in wound care assessment, for assessing symptomatic PAD, and as a screening device for PAD. It may also be used on patients with venous or arterial ulcers prior to application of compression therapy. ABPI MD system can be used on patients with unilateral lower limb amputation. The ABPI MD system is intended to be used to spot-check patients. The ABPI MD system provides information regarding patient risk. The physician has the responsibility of making proper judgments based on this information. Prescription Use: Federal law restricts the use of this device to sale by or on the order of a physician.
    Device Description
    The ABPI MD system, is an automated ankle brachial pressure index measuring device, the system includes the following components: - -ABPI measuring unit - -Arm cuff size M - -Left ankle cuff size M - -Right ankle cuff size M - -AC/DC power supply - Tubes - - -USB cable - -Instructions for use, Installation and User guide, Certificate of Calibration, Certificate of Conformity and Warranty - Software installed on a computer - It is intended to measure a patient's Ankle Brachial Pressure Index (ABPI) and Ankle Brachial Index (ABI) and provides Pulse Volume Recording (PVR) / volume plethysmography. This is done through an automated process. The operator places the three color coded cuffs on the right or left arm, and on each ankle as described in the instructions for use, and connects to the device. When connected, the operator clicks start button to begin measurement. The device will then automatically control the inflation of the cuffs and monitor variations in individual pressures to determine values to be used for the calculation of the ABI values for the both left and right of the patient.
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