The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Nuvant, Mobile Cardiac Telemetry.
| Device ID | K111917 |
| 510k Number | K111917 |
| Device Name: | NUVANT, MOBILE CARDIAC TELEMETRY |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul, MN 55108 |
| Contact | Michele Chin-purcell |
| Correspondent | Michele Chin-purcell CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul, MN 55108 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-06 |
| Decision Date | 2011-08-24 |
| Summary: | summary |