The following data is part of a premarket notification filed by Sotera Wireless, Inc. with the FDA for Visi Mobile Monitoring System, Visi Mobile Chest Sensor.
| Device ID | K142827 |
| 510k Number | K142827 |
| Device Name: | Visi Mobile Monitoring System, Visi Mobile Chest Sensor |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Sotera Wireless, Inc. 10020 Huennekens Street San Diego, CA 92121 |
| Contact | Eben Gordon |
| Correspondent | Eben Gordon Sotera Wireless, Inc. 10020 Huennekens Street San Diego, CA 92121 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-30 |
| Decision Date | 2015-07-20 |
| Summary: | summary |