510(k) K130659 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SPEQRT ULTRASOUND SYSTEM
| Applicant | Signostics Pty, Ltd., Thebarton Sa, AU |
| Decision | Substantially Equivalent, Apr 3, 2013 |
| Received | Mar 12, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K130659
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.