510(k) K211665 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONON Ultrasound Imaging System, Model: SONON300C
| Applicant | Healcerion Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, May 16, 2022 |
| Received | Jun 1, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K211665
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.