510(k) K061068 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
EG-3670URK
| Applicant | Pentax Medical Company, Montvale NJ, US |
| Decision | Substantially Equivalent, May 3, 2006 |
| Received | Apr 17, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061068
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2017 | Pentax of America Inc Ultrasound Video Gastroscope, Model EG-3670URK,
The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical vide Terminated |
ODG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.