510(k) K010740 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
FG-36UX, FIBER ULTRASOUND GASTROSCOPE
| Applicant | Pentax Precision Instrument Corp., Orangeburg NY, US |
| Decision | Substantially Equivalent, Apr 17, 2001 |
| Received | Mar 13, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010740
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.