K182224 is an FDA 510(k) clearance for the SafeAir Smoke Evacuator compact. This device is classified as a Apparatus, Exhaust, Surgical (Class II - Special Controls, product code FYD).
Submitted by Lina Medical Aps (Tarnowo Podgorne, PL). The FDA issued a Cleared decision on February 7, 2019, 175 days after receiving the submission on August 16, 2018.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 878.5070.
| 510(k) Number | K182224 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 16, 2018 |
| Decision Date | February 07, 2019 |
| Days to Decision | 175 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FYD - Apparatus, Exhaust, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 878.5070 |