The following data is part of a premarket notification filed by Intelesens, Ltd. with the FDA for Aingeal Activity System.
| Device ID | K153275 |
| 510k Number | K153275 |
| Device Name: | Aingeal Activity System |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Intelesens, Ltd. 17 Heron Road Belfast, GB Bt3 9le |
| Contact | Patricia Pepper |
| Correspondent | Paul Dryden Intelesens, Ltd. 17 Heron Road Belfast, GB Bt3 9le |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-02-26 |
| Summary: | summary |