The following data is part of a premarket notification filed by Sotera Wireless, Inc with the FDA for Visi Mobile Monitoring System.
| Device ID | K122036 |
| 510k Number | K122036 |
| Device Name: | VISI MOBILE MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | SOTERA WIRELESS, INC 9444 WAPLES STREET SUITE 280 San Diego, CA 92121 |
| Contact | Eben Gordon |
| 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 |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2012-07-11 |
| Decision Date | 2012-08-15 |
| Summary: | summary |