510(k) K161300 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Acclarix AX8 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, May 31, 2016 |
| Received | May 9, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161300
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.