510(k) K120392 ยท FSY Light, Surgical, Ceiling Mounted
CHROMOPHARE F 628 AND F 528
| Applicant | Berchtold GmbH & Co. KG, Tuttlingen, DE |
| Decision | Substantially Equivalent, Feb 16, 2012 |
| Received | Feb 8, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120392
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 27, 2026 | Stryker Communications Stryker CHROMOPHARE Softlit Ring Surgical Light System
REF: CH00000001 Open, Classified |
FSY | None listed |
| Apr 9, 2024 | Stryker Communications Chromophare Surgical Light System , REF CH00000001 Open, Classified |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.