The following data is part of a premarket notification filed by Tosense, Inc. with the FDA for Cova Monitoring System.
| Device ID | K142087 |
| 510k Number | K142087 |
| Device Name: | COVA MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | toSense, Inc. 4225 EXECUTIVE SQUARE, SUITE 570 La Jolla, CA 92037 |
| Contact | Nandini Mirthy |
| Correspondent | Nandini Mirthy toSense, Inc. 4225 EXECUTIVE SQUARE, SUITE 570 La Jolla, CA 92037 |
| Product Code | MWI |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-30 |
| Decision Date | 2015-05-01 |
| Summary: | summary |