The following data is part of a premarket notification filed by Adherium (nz) Ltd with the FDA for Hailie Sensor Nf0107 & Nf0108.
| Device ID | K221994 |
| 510k Number | K221994 |
| Device Name: | Hailie Sensor NF0107 & NF0108 |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Adherium (NZ) Ltd Level 11, 16 Kingston Street Auckland, NZ 1010 |
| Contact | Tara Creaven-Capasso |
| Correspondent | Tara Creaven-Capasso Adherium (NZ) Ltd Level 11, 16 Kingston 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 | 2022-07-06 |
| Decision Date | 2022-10-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09421032180415 | K221994 | 000 |
| 09421032180408 | K221994 | 000 |