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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 the device name listed in this FDA 510(k) record. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. It received FDA 510(k) clearance on 2020-12-11 under 510(k) 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. The listed applicant is Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd.. The 510(k) number is K201046.

When did Automated ankle brachial pressure index measuring device, MESI mTABLET system receive FDA 510(k) clearance?

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

Who is the listed applicant for Automated ankle brachial pressure index measuring device, MESI mTABLET system?

The FDA 510(k) record lists Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06557538A Comparison of Automatic ABPI vs Manual ABPI Device ScoresCOMPLETEDNCT07226193Detecting Peripheral Artery Disease With the PulseRECRUITINGNCT03203239Red Light Treatment in Peripheral Artery DiseaseRECRUITING

Other records listing Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K172655Automated ankle brachial pressure index measuring device

Related Devices (Code: JOM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K220527PADnet XpressCollaborative Care Diagnostics, LLC, D.B.A. BiomedixK213730MESI mTABLET TBI diagnostic system, MESI mTABLET TBIMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.K200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K191266VitalScan ANSMedeia, Inc.K172655Automated ankle brachial pressure index measuring deviceMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.K173696TBL-ABI SystemLd Technology, LLC

Official Source

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