K182638 is an FDA 510(k) clearance for the Hailie Sensor. This device is classified as a Nebulizer (direct Patient Interface) (Class II - Special Controls, product code CAF).
Submitted by Adherium (Nz), Ltd. (Auckland, NZ). The FDA issued a Cleared decision on June 19, 2019, 268 days after receiving the submission on September 24, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K182638 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2018 |
| Decision Date | June 19, 2019 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Anesthesiology (AN) |
| Summary | Summary PDF |
| Product Code | CAF - Nebulizer (direct Patient Interface) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 868.5630 |