510(k) K002198 ยท OWB Interventional Fluoroscopic X-Ray System
FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS
| Applicant | Fluoro Scan Imaging Systems, Inc., Northbrook IL, US |
| Decision | Substantially Equivalent, Oct 17, 2000 |
| Received | Jul 20, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002198
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.