510(k) K211232 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Apache Ultrasound System
| Applicant | Aco Healthcare Co., Ltd., Hsinchu, TW |
| Decision | Substantially Equivalent, Jun 25, 2021 |
| Received | Apr 23, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211232
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.