510(k) K963952 ยท OWB Interventional Fluoroscopic X-Ray System
SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM
| Applicant | Ge Dec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Dec 23, 1996 |
| Received | Oct 2, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963952
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 20, 2008 | OEC Medical Systems, Inc GE OEC 9600 C-arm Fluoroscopy System, 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.