MESI MTABLET TBI Diagnostic System, MESI MTABLET TBI

Plethysmograph, Photoelectric, Pneumatic Or Hydraulic

Mesi, Development Of Medical Devices, Ltd.; Mesi D.o.o.

The following data is part of a premarket notification filed by Mesi, Development Of Medical Devices, Ltd.; Mesi D.o.o. with the FDA for Mesi Mtablet Tbi Diagnostic System, Mesi Mtablet Tbi.

Pre-market Notification Details

Device IDK213730
510k NumberK213730
Device Name:MESI MTABLET TBI Diagnostic System, MESI MTABLET TBI
ClassificationPlethysmograph, Photoelectric, Pneumatic Or Hydraulic
Applicant Mesi, Development Of Medical Devices, Ltd.; Mesi D.o.o. Leskoskova Cesta 11A Ljubljana,  SI 1000
ContactJakob Susteric
CorrespondentElaine Duncan
Paladin Medical, Inc. P.O. Box 560 Stillwater,  MN  55082
Product CodeJOM  
CFR Regulation Number870.2780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-26
Decision Date2022-04-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03830059851523 K213730 000

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