The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Hailie Sensor.
| Device ID | K182638 |
| 510k Number | K182638 |
| Device Name: | Hailie Sensor |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010 |
| Contact | Chris Mander |
| Correspondent | Chris Mander Adherium (NZ) Ltd Level 2, 204 Quay Street Auckland, NZ 1010 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-06-19 |