510(k) K112953 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
TERASON T3000 ULTRASOUND SYSTEMS WITH UPDATED NEEDLE GUIDANCE GRAPHICS
| Applicant | Teratech Corp., Burlington MA, US |
| Decision | Substantially Equivalent, Feb 3, 2012 |
| Received | Oct 4, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112953
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.