The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Nuvant, Mobilc Cardiac Telemetry.
| Device ID | K113372 |
| 510k Number | K113372 |
| Device Name: | NUVANT, MOBILC CARDIAC TELEMETRY |
| 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 |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-16 |
| Decision Date | 2012-03-07 |
| Summary: | summary |