The following data is part of a premarket notification filed by Intelesens Limited with the FDA for Vitalsens, Aingeal, V-pod.
| Device ID | K110015 |
| 510k Number | K110015 |
| Device Name: | VITALSENS, AINGEAL, V-POD |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| 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 | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-03 |
| Decision Date | 2011-05-20 |
| Summary: | summary |