510(k) K970063 ยท OWB Interventional Fluoroscopic X-Ray System
SERIES 7600 MOBILE DIGITAL C-ARM
| Applicant | Ge Dec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Mar 11, 1997 |
| Received | Jan 7, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970063
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2008 | GE OEC Medical Systems, Inc GE Healthcare, Mobile Fluoroscopy X-Ray System, OEC Model 7600, GE Healthcare, Surgery, Salt Lake City, Utah. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.