510(k) K090197 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
EG-3870UTK
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, May 19, 2009 |
| Received | Jan 27, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090197
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Pentax of America Inc Ultrasound Video Gastroscope, Model EG-3870UTK.
The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video Terminated |
ODG | None listed |
| May 3, 2012 | Pentax Medical Company EG-3870UTK, Pentax Ultrasound Video Gastroscope.
The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and th Terminated |
ITX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.