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K Number
K213730
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)

Product Code
JOM
Regulation Number
870.2780
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
Device Description
AI/ML Overview

§ 870.2780 Hydraulic, pneumatic, or photoelectric plethysmographs.

(a)
Identification. A hydraulic, pneumatic, or photoelectric plethysmograph is a device used to estimate blood flow in a region of the body using hydraulic, pneumatic, or photoelectric measurement techniques.(b)
Classification. Class II (performance standards).