510(k) K203128 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2/EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME2 PREMIER PLUS
| Applicant | Olympus Medical Systems Corp., Hachioji-Shi, JP |
| Decision | Substantially Equivalent, Nov 9, 2020 |
| Received | Oct 19, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203128
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.