The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Avivo Mobile Patient Management System, Nuvant Mobile Cardiac Telemetry (mct) System.
| Device ID | K091971 |
| 510k Number | K091971 |
| Device Name: | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM, NUVANT MOBILE CARDIAC TELEMETRY (MCT) SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CORVENTIS, INC. 2033 GATEWAY PLACE SUITE 100 San Jose, CA 95110 |
| Contact | Madhuri Bhat |
| Correspondent | Madhuri Bhat CORVENTIS, INC. 2033 GATEWAY PLACE SUITE 100 San Jose, CA 95110 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2009-08-27 |
| Summary: | summary |