510(k) K954169 ยท FSY Light, Surgical, Ceiling Mounted
HANAULUX BLUE 30 & 80
| Applicant | Heraeus Med GmbH, Hanau, DE |
| Decision | Substantially Equivalent, Feb 1, 1996 |
| Received | Sep 5, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954169
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Blueline Series 30/80 OR Light Systems, Model Numbers and Catalog Numbers BLUE 30 - ARD569015111A, BLUE 30 - ARD569015111C, BLUE 30 - ARD569015131C, BLUE 30 - ARD569025111C, BLUE 30 - ARD569025 Open, Classified |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.