The following data is part of a premarket notification filed by Intelesens Limited with the FDA for V-patch System.
| Device ID | K131000 |
| 510k Number | K131000 |
| Device Name: | V-PATCH SYSTEM |
| Classification | Detector And Alarm, Arrhythmia |
| Applicant | INTELESENS LIMITED 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden INTELESENS LIMITED 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 |
| Product Code | DSI |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-04-10 |
| Decision Date | 2014-01-08 |
| Summary: | summary |