510(k) K170085 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONON Ultrasound Imaging System, Model: 300L
| Applicant | Healcerion Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Oct 12, 2017 |
| Received | Jan 10, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170085
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.