510(k) K112539 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
CHISON DIGITAL ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, TRANSVAGINAL MICRO-CONVEX PROBE, TRANSRECTAL LINEAR PROBE
| Applicant | Leiker Regulatory & Quality Consulting, Dublin CA, US |
| Decision | Substantially Equivalent, Jan 30, 2012 |
| Received | Sep 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112539
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.