The following data is part of a premarket notification filed by Sotera Wireless, Inc with the FDA for Visi Mobile Monitoring System.
| Device ID | K152341 |
| 510k Number | K152341 |
| Device Name: | ViSi Mobile Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SOTERA WIRELESS, INC 10020 Huennekens Street San Diego, CA 92121 |
| Contact | Carson Krupp |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-08-19 |
| Decision Date | 2015-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850733007094 | K152341 | 000 |
| 00850733007377 | K152341 | 000 |
| 00850733007353 | K152341 | 000 |
| 00850733007339 | K152341 | 000 |
| 00850733007315 | K152341 | 000 |
| 00850733007278 | K152341 | 000 |
| 00850733007254 | K152341 | 000 |
| 00850733007230 | K152341 | 000 |
| 00850733007216 | K152341 | 000 |
| 00850733007193 | K152341 | 000 |
| 00850733007162 | K152341 | 000 |
| 00850733007155 | K152341 | 000 |
| 00850733007384 | K152341 | 000 |
| 00850733007407 | K152341 | 000 |
| 00850733007414 | K152341 | 000 |
| 00850733007087 | K152341 | 000 |
| 00850733007070 | K152341 | 000 |
| 00850733007063 | K152341 | 000 |
| 00850733007056 | K152341 | 000 |
| 00850733007049 | K152341 | 000 |
| 10850733007039 | K152341 | 000 |
| 00850733007025 | K152341 | 000 |
| 00850733007018 | K152341 | 000 |
| 00850733007001 | K152341 | 000 |
| 10850733007305 | K152341 | 000 |
| 00850733007186 | K152341 | 000 |
| 00850733007148 | K152341 | 000 |