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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 a medical device manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. It received FDA 510(k) clearance on 2022-04-21 under approval 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. It is manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.. The 510(k) number is K213730.

When was MESI mTABLET TBI diagnostic system, MESI mTABLET TBI approved by the FDA?

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

What company makes MESI mTABLET TBI diagnostic system, MESI mTABLET TBI?

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI is manufactured by Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O..

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.

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Related PubMed Literature

PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 39943397 Clinical Validation of a Video-Otoscopy-Based Medical Device for the Remote Diagnosis of Ear Complaints. Sensors (Basel, Switzerland) (2025) PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

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

K223670MESI mTablet ECG Diagnostic System, MESI mTablet ECG

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. 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

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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