The following data is part of a premarket notification filed by Mesi D.o.o.; Mesi, Development Of Medical Devices, Ltd. with the FDA for Automated Ankle Brachial Pressure Index Measuring Device.
| Device ID | K172655 |
| 510k Number | K172655 |
| Device Name: | Automated Ankle Brachial Pressure Index Measuring Device |
| Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
| Applicant | Mesi D.O.O.; Mesi, Development Of Medical Devices, Ltd. Letaliska Cesta 3C 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 | 2017-09-05 |
| Decision Date | 2018-01-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03830059850366 | K172655 | 000 |