510(k) K000221 ยท OWB Interventional Fluoroscopic X-Ray System
SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM
| Applicant | Ge Dec Medical Systems, Salt Lake City UT, US |
| Decision | Substantially Equivalent, Apr 11, 2000 |
| Received | Jan 24, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K000221
| 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 7700, 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.