The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Nuvant Cardiac Event Monitoring System; Nuvant Mobile Cardiac Telemetry System.
| Device ID | K090696 |
| 510k Number | K090696 |
| Device Name: | NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CORVENTIS, INC. 2226 N. FIRST STREET San Jose, CA 95131 |
| Contact | Madhuri Bhat |
| Correspondent | Madhuri Bhat CORVENTIS, INC. 2226 N. FIRST STREET San Jose, CA 95131 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-06-19 |
| Summary: | summary |