MESI mTABLET TBI diagnostic system, MESI mTABLET TBI— 510(k) K213730

Substantially Equivalent

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

FDA 510(k) clearance K213730 for MESI mTABLET TBI diagnostic system, MESI mTABLET TBI, Substantially Equivalent on 2022-04-21. Applicant: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O..

Clearance details

Applicant: Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O.
Product code: Code JOM
Advisory panel: Cardiovascular
Date received: 2021-11-26
Decision date: 2022-04-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ljubljana, SI

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