510(k) K140461 ยท FSY Light, Surgical, Ceiling Mounted
MACH LED 2MC
| Applicant | Dr. Mach GmbH & Co. KG, Norderstedt, Schleswig-Holstein, DE |
| Decision | Substantially Equivalent, Apr 3, 2014 |
| Received | Feb 24, 2014 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K140461
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.