510(k) K180862 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 Diagnostic Ultrasound System
| Applicant | Edan Instruments, Inc., Shenzhen, CN |
| Decision | Substantially Equivalent, May 24, 2018 |
| Received | Apr 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180862
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.