510(k) K063847 ยท FDS Gastroscope And Accessories, Flexible/Rigid
FUJINON ULTRASONIC ENDOSCOPE AND PROCESSOR, MODELS EG-530UR, EG-530UT AND SU-700
| Applicant | Fujinon, Inc., Shelton CT, US |
| Decision | Substantially Equivalent, Mar 1, 2007 |
| Received | Dec 27, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063847
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 17, 2017 | Fujifilm Medical Systems U.S.A., Inc. Ultrasonic Endoscope
Model Number EG-530UT
A flexible ultrasonic endoscope intended to provide ultrasonic images of submucosal and peripheral organs Terminated |
FDS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.