510(k) K050326 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350
| Applicant | Esaote, S.p.A., Indianpolis IN, US |
| Decision | Substantially Equivalent, Feb 28, 2005 |
| Received | Feb 9, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050326
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2014 | Biosound Esaote, Inc. Esaote PA230E Transducer
A portable and cart base ultrasound system for general and cardiovascular imaging Terminated |
JOP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.