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.
| Device ID | K213730 |
| 510k Number | K213730 |
| Device Name: | MESI MTABLET TBI Diagnostic System, MESI MTABLET TBI |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | Mesi, Development Of Medical Devices, Ltd.; Mesi D.o.o. Leskoskova Cesta 11A Ljubljana, SI 1000 |
| Contact | Jakob Susteric |
| Correspondent | Elaine Duncan Paladin Medical, Inc. P.O. Box 560 Stillwater, MN 55082 |
| Product Code | JOM |
| CFR Regulation Number | 870.2780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-26 |
| Decision Date | 2022-04-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830059851523 | K213730 | 000 |