510(k) K073542 ยท ITH Equipment, Traction, Powered
CYCLETRAC CT-5000
| Applicant | Pt Products, LLC, Farmington Hills MI, US |
| Decision | Substantially Equivalent, Feb 14, 2008 |
| Received | Dec 17, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K073542
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 5, 2009 | OEC Medical Systems, Inc GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy. Terminated |
JAA | None listed |
| Jan 5, 2009 | OEC Medical Systems, Inc GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City, UT. The system is intended to provide an x-ray display of human anatomy. Terminated |
JAA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.