510(k) K100395 ยท FST Light, Surgical, Fiberoptic
HARMONY VLED SURGICAL LIGHTNING SYSTEM
| Applicant | STERIS Corporation, Mentor OH, US |
| Decision | Substantially Equivalent, Mar 17, 2010 |
| Received | Feb 16, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100395
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2015 | Steris Corporation Harmony vLED Surgical Lighting System, one unit packaged per box
The Harmony vLED Surgical Lighting System is a variable pattern, variable intensity surgical lighting fixture designed to provide visib Terminated |
FST | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.