510(k) K190186 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Mar 28, 2019 |
| Received | Feb 1, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190186
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.