The following data is part of a premarket notification filed by Sotera Wireless, Inc. with the FDA for Visi Mobile Monitoring System.
| Device ID | K180472 |
| 510k Number | K180472 |
| Device Name: | ViSi Mobile Monitoring System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Sotera Wireless, Inc. 10020 Huenneckens Street Lan Herrington, CA 92121 |
| Contact | Lan Herrington |
| Correspondent | Frank Pokrop Sotera Wireless, Inc. 10020 Huenneckens Street San Diego, CA 92121 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2018-06-19 |
| Summary: | summary |