510(k) K131830 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM
| Applicant | Edan Instruments, Inc., Shenzhen, Guangdong, CN |
| Decision | Substantially Equivalent, Sep 17, 2013 |
| Received | Jun 20, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131830
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.