510(k) K011693 ยท FSY Light, Surgical, Ceiling Mounted
TRUMPF SURGICAL LIGHTS, MODELS 301,501,701,1001
| Applicant | Trumpf Medical Systems, Inc., Charleston SC, US |
| Decision | Substantially Equivalent, Jun 13, 2001 |
| Received | May 31, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011693
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 7, 2015 | Trumpf Medical Systems, Inc. Trumpf Ceiling Mounted Surgical Lighting Systems,Helion/Xenion S/M/L, User Manual #1441784.
The TRUMPF surgical lights are intended to locally illuminate an operating or examination area of the patie Terminated |
FSY | None listed |
| Dec 12, 2013 | Trumpf Medical Systems, Inc. Helion S Exam Light or H300
The device is intended to locally illuminate an examination area of the patient's body with high intensity light in a clinic or doctor's practice. Terminated |
FSY | None listed |
| Oct 18, 2012 | Trumpf Medical Systems, Inc. Helion and Xenion surgical lights, 501/01 series KLM lights.
The surgical lights are intended to locally illuminate an operating or examination area of the patients body with a high intensity light. Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.