510(k) K130247 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Mar 20, 2013 |
| Received | Feb 1, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130247
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.