FDA 510(k)

Automated ankle brachial pressure index measuring device, MESI mTABLET system

K-Nummer: K201046 · 2020-12-11

AntragstellerMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.

Entscheidungsdatum2020-12-11

ProduktcodeJOM

BeratungsausschussCV

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Weitere Einträge mit Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. als Antragsteller

K172655Automated ankle brachial pressure index measuring device

Verwandte Geräte (Code: JOM)

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.K200567ASI Plethysmografie-AnalysegerätArterial 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

Offizielle Quelle

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