510(k) K203166 ยท ODG Endoscopic Ultrasound System, Gastroenterology-Urology
PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U
| Applicant | Pentax of America, Inc., Montvale NJ, US |
| Decision | Substantially Equivalent, Dec 30, 2020 |
| Received | Oct 23, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203166
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.