BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇸🇮 Slovenia

    Automated ankle brachial pressure index measuring device, MESI mTABLET system

    K Number: K201046 · Decision Dec 11, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    52
    Applicant Total
    2
    Review Days
    234

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    Automated ankle brachial pressure index measuring device, MESI mTABLET system
    K Number
    K201046
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    870.2780
    Medical Specialty
    Cardiovascular
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
    Date Received
    April 21, 2020
    Decision Date
    December 11, 2020
    Product Code
    JOM
    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
    JOM Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (JOM), ordered by most recent decision date.

    PADnet Xpress

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ASI Plethysmogrpah Analyzer

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VitalScan ANS

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Automated ankle brachial pressure index measuring device

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    TBL-ABI System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular
    View all

    Other Clearances by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

    K Number Device Name
    K172655 Automated ankle brachial pressure index measuring device