510(k) K171824 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, Jul 18, 2017 |
| Received | Jun 19, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171824
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.