The following data is part of a premarket notification filed by Corventis, Inc. with the FDA for Nuvant Mct System.
| Device ID | K133701 |
| 510k Number | K133701 |
| Device Name: | NUVANT MCT SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul, MN 55108 |
| Contact | Cheryl Swanson |
| Correspondent | Cheryl Swanson CORVENTIS, INC. 1410 ENERGY PARK DRIVE, SUITE 1 St. Paul, MN 55108 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-03 |
| Decision Date | 2014-02-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169513686 | K133701 | 000 |
| 00763000057152 | K133701 | 000 |
| 00763000057176 | K133701 | 000 |
| 00763000057190 | K133701 | 000 |
| 00763000057206 | K133701 | 000 |
| 00763000057213 | K133701 | 000 |
| 00763000065638 | K133701 | 000 |
| 00763000065645 | K133701 | 000 |
| 00763000065652 | K133701 | 000 |
| 00763000065669 | K133701 | 000 |
| 00763000065737 | K133701 | 000 |
| 00763000065744 | K133701 | 000 |
| 00643169513570 | K133701 | 000 |
| 00643169513600 | K133701 | 000 |
| 00643169513631 | K133701 | 000 |
| 00643169513648 | K133701 | 000 |
| 00643169513655 | K133701 | 000 |
| 00763000057138 | K133701 | 000 |