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FDA 510(k)

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

K-Number: K213730 · 2022-04-21

ApplicantMesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Decision Date2022-04-21
Product CodeJOM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is the device name listed in this FDA 510(k) record. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213730. 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 MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The 510(k) number is K213730.

When did MESI mTABLET TBI diagnostic system, MESI mTABLET TBI receive FDA 510(k) clearance?

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213730.

Who is the listed applicant for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

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

What is the FDA product code for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

The FDA product code for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is JOM.

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

K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECG

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. BiomedixK200567ASI Plethysmogrpah AnalyzerArterial Stiffness, Inc.K201046Automated ankle brachial pressure index measuring device, MESI mTABLET systemMesi D.O.O.; Mesi, Development of Medical Devices, Ltd.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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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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