The following data is part of a premarket notification filed by Jolife Ab with the FDA for Lucas 3 Chest Compression System.
Device ID | K173553 |
510k Number | K173553 |
Device Name: | LUCAS 3 Chest Compression System |
Classification | Compressor, Cardiac, External |
Applicant | Jolife AB Scheelevagen 17 Ideon Science Park Lund, SE 22370 |
Contact | Malin Melander |
Correspondent | John J. Smith Hogan Lovells US LLP 555 Thirteenth 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 | 2017-11-16 |
Decision Date | 2018-02-08 |
Summary: | summary |