510(k) K970886 ยท FSS Light, Surgical, Floor Standing
HANAULUX BLUE 80 HOSPITAL
| Applicant | Heraeus Med GmbH, Hanau, DE |
| Decision | Substantially Equivalent, Apr 16, 1997 |
| Received | Feb 6, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970886
| 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.