The following data is part of a premarket notification filed by Lina Medical Aps with the FDA for Safeair Smoke Evacuator Compact.
| Device ID | K182224 |
| 510k Number | K182224 |
| Device Name: | SafeAir Smoke Evacuator Compact |
| Classification | Apparatus, Exhaust, Surgical |
| Applicant | LiNA Medical APS ul. Rolna 8A, Sady Tarnowo Podgorne, PL 62-080 |
| Contact | Natalia Szychulska |
| Correspondent | Kevin F. Macdonald Kevin F. MacDonald 4297 D Street Sacramento, CA 95819 |
| Product Code | FYD |
| CFR Regulation Number | 878.5070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-16 |
| Decision Date | 2019-02-07 |
| Summary: | summary |