510(k) K030906 ยท FSY Light, Surgical, Ceiling Mounted
AXCEL SURGICAL LIGHT
| Applicant | Alm, Rochester NY, US |
| Decision | Substantially Equivalent, Apr 23, 2003 |
| Received | Mar 24, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K030906
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Axcel / Axcel + OR Light Systems, Model Numbers and Catalog Numbers AXL 5001 - ARD567501961C, AXL 5001S - ARD567505961C, AXL 5002 - ARD567501962C, AXL 5002S - ARD567505962C, AXL 5501 - ARD56750 Open, Classified |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.