The following data is part of a premarket notification filed by Jolife Ab with the FDA for Lucas 3 Chest Compression System.
| Device ID | K161768 |
| 510k Number | K161768 |
| Device Name: | LUCAS 3 Chest Compression System |
| Classification | Compressor, Cardiac, External |
| Applicant | Jolife AB Scheelevagen 17, Ideon Science Park Lund, SE 223 70 |
| Contact | Malin Melander |
| Correspondent | John J. Smith Hogan Lovells US LLP 555 13th Street NW Washington, DC 20004 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-06-27 |
| Decision Date | 2016-11-09 |
| Summary: | summary |