The following data is part of a premarket notification filed by Tosense, Inc. with the FDA for Cova Monitoring System 2.
| Device ID | K160899 |
| 510k Number | K160899 |
| Device Name: | CoVa Monitoring System 2 |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | TOSENSE, INC. 4225 EXECUTIVE SQUARE SUITE 570 La Jolla, CA 92037 |
| Contact | Susan Pede |
| Correspondent | Susan Pede TOSENSE, INC. 4225 EXECUTIVE SQUARE SUITE 570 La Jolla, CA 92037 |
| Product Code | MWI |
| Subsequent Product Code | DSB |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-01 |
| Decision Date | 2017-06-22 |
| Summary: | summary |