510(k) K162447 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Apr 13, 2017 |
| Received | Sep 1, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K162447
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.