510(k) K113156 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONOSITE EDGE ULTRASOUND SYSTEM
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Nov 15, 2011 |
| Received | Oct 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113156
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2013 | SonoSite, Inc. P21x/5-1 MHz transducer, Part Number P07698-23
Product Usage: The P21x/5-1 MHz phased array transducer is designed for cardiac, abdominal and obstetric, TCD and orbital exams. It supports 2D with So Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.