K182573 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 7, 2019, 262 days after receiving the submission on September 18, 2018.
This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.5630.
| 510(k) Number | K182573 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 18, 2018 |
| Decision Date | June 07, 2019 |
| Days to Decision | 262 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 |