The following data is part of a premarket notification filed by Sotera Wireless, Inc. with the FDA for Visi Mobile Monitoring System.
| Device ID | K150361 |
| 510k Number | K150361 |
| 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 | Carson Krupp Sotera Wireless, Inc. 10020 Huennekens Street San Diego, CA 92121 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-12 |
| Decision Date | 2015-04-30 |
| Summary: | summary |