510(k) K113679 ยท NTN Led Light Source
LUCEA LED SURGICAL LIGHT SYSTEM
| Applicant | Maquet S.A.S., Wayne NJ, US |
| Decision | Substantially Equivalent, Jan 12, 2012 |
| Received | Dec 14, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113679
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDL Open, Classified |
FTD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.