The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Avivo Mobile Patient Management System.
| Device ID | K083287 |
| 510k Number | K083287 |
| Device Name: | AVIVO MOBILE PATIENT MANAGEMENT SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CORVENTIS, INC. 2226 N. FIRST STREET San Jose, CA 95131 |
| Contact | Dawn Chang |
| Correspondent | Dawn Chang CORVENTIS, INC. 2226 N. FIRST STREET San Jose, CA 95131 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-07 |
| Decision Date | 2009-02-03 |
| Summary: | summary |