The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Avivo Mobile Patient Management.
| Device ID | K113187 |
| 510k Number | K113187 |
| Device Name: | AVIVO MOBILE PATIENT MANAGEMENT |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CORVENTIS, INC. 1410 ENERGY PARK DRIVE SUITE 1 Saint Paul, MN 55108 |
| Contact | Kathleen Lundberg |
| Correspondent | Kathleen Lundberg CORVENTIS, INC. 1410 ENERGY PARK DRIVE SUITE 1 Saint Paul, MN 55108 |
| Product Code | MHX |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-31 |
| Decision Date | 2012-01-04 |
| Summary: | summary |