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FDA 510(k)

Automated ankle brachial pressure index measuring device

K-Number: K172655 · 2018-01-11

ApplicantMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.
Decision Date2018-01-11
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Automated ankle brachial pressure index measuring device is a medical device manufactured by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. It received FDA 510(k) clearance on 2018-01-11 under approval number K172655. 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?

Automated ankle brachial pressure index measuring device is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. The 510(k) number is K172655.

When was Automated ankle brachial pressure index measuring device approved by the FDA?

Automated ankle brachial pressure index measuring device received FDA 510(k) clearance on 2018-01-11, under approval number K172655.

What company makes Automated ankle brachial pressure index measuring device?

Automated ankle brachial pressure index measuring device 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?

The FDA product code for Automated ankle brachial pressure index measuring device is JOM.

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Related PubMed Literature

PMID: 41929241 A Multidimensional Index Framework for Evaluating the Regulatory Applicability of ISO 10328 Using a Prosthetic Knee Case Study. Medical devices (Auckland, N.Z.) (2026) PMID: 41836285 A Case Study of AI-Enabled Software as a Medical Device Cleared by the FDA for Assessing Hemorrhage Risk Index (APPRAISE-HRI) after Trauma. NEJM AI (2025) PMID: 41702410 FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976-2025. Expert review of medical devices (2026) PMID: 40388896 Accuracy and Safety of a Continuous Noninvasive Blood Pressure Monitor in Neonates. Neonatology (2025)

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

K201046Automated ankle brachial pressure index measuring device, MESI mTABLET system

Related Devices (Code: JOM)

K173696TBL-ABI SystemLd Technology, LLC K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi 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

View on FDA Database →

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

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