The following data is part of a premarket notification filed by Jolife Ab with the FDA for Lucas 2.
| Device ID | K090422 |
| 510k Number | K090422 |
| Device Name: | LUCAS 2 |
| Classification | Compressor, Cardiac, External |
| Applicant | JOLIFE AB 555 13TH ST. NW Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein JOLIFE AB 555 13TH ST. 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 | 2009-02-18 |
| Decision Date | 2009-06-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883873948323 | K090422 | 000 |
| 00883873881453 | K090422 | 000 |