510(k) K150999 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
Acclarix Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shekou, CN |
| Decision | Substantially Equivalent, May 6, 2015 |
| Received | Apr 15, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150999
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.