510(k) K101337 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
A6 PORTABLE ULTRASONIC DIAGNOSTIC SYSTEM
| Applicant | Sonoscape Company Limited, Shanghai, CN |
| Decision | Substantially Equivalent, Sep 30, 2010 |
| Received | May 12, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K101337
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.