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510(k) Data Aggregation

K Number

Device Name

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

Manufacturer

Mesi, Development of Medical Devices, Ltd.; Mesi d.o.o.

Date Cleared

2022-04-21

(146 days)

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Panel

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N/A

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Device Name :

MESI mTABLET TBI diagnostic system, MESI mTABLET TBI

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

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