The following data is part of a premarket notification filed by Sotera Wireless, Inc with the FDA for Visi Mobile Monitoring System.
| Device ID | K112478 |
| 510k Number | K112478 |
| Device Name: | VISI MOBILE MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SOTERA WIRELESS, INC 9444 WAPLES STREET San Diego, CA 92121 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon SOTERA WIRELESS, INC 9444 WAPLES STREET San Diego, CA 92121 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-29 |
| Decision Date | 2012-03-22 |
| Summary: | summary |