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FDA 510(k)

Automated ankle brachial pressure index measuring device, MESI mTABLET system

K-Number: K201046 · 2020-12-11

ApplicantMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Decision Date2020-12-11
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automated ankle brachial pressure index measuring device, MESI mTABLET system is a medical device manufactured by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. It received FDA 510(k) clearance on 2020-12-11 under approval number K201046. The device is classified under product code JOM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Automated ankle brachial pressure index measuring device, MESI mTABLET system?

Automated ankle brachial pressure index measuring device, MESI mTABLET system is a medical device that received FDA 510(k) clearance on 2020-12-11. It is manufactured by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. The 510(k) number is K201046.

When was Automated ankle brachial pressure index measuring device, MESI mTABLET system approved by the FDA?

Automated ankle brachial pressure index measuring device, MESI mTABLET system received FDA 510(k) clearance on 2020-12-11, under approval number K201046.

What company makes Automated ankle brachial pressure index measuring device, MESI mTABLET system?

Automated ankle brachial pressure index measuring device, MESI mTABLET system is manufactured by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd..

What is the FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

The FDA product code for Automated ankle brachial pressure index measuring device, MESI mTABLET system is JOM.

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Related PubMed Literature

PMID: 42201559 Time-series and thematic analyses of clinical utilities and operational issues in early clinical studies of the da Vinci surgical system. Journal of robotic surgery (2026) PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 41966529 Comparison of the AccuPower HIV-1 Quant Kit and Aptima HIV-1 Quant Dx Assay for quantification of HIV-1 plasma viral load. Diagnostic microbiology and infectious disease (2026)

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

K172655Automated ankle brachial pressure index measuring device

Related Devices (Code: JOM)

K173696TBL-ABI SystemLd Technology, LLC K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd. K191266VitalScan ANSMedeia, Inc. K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc. K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. Biomedix K213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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