510(k) K071134 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SONOSITE MAXX SERIES DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, May 8, 2007 |
| Received | Apr 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071134
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 18, 2011 | Sonosite, Inc. MicroMaxx ultrasound system and M-Turbo ultrasound system is Medical Diagnostic Ultrasound.
General purpose ultrasound system intended for use by a qualified physician for evaluation by ultrasound im Terminated |
IYN | None listed |
| Aug 9, 2010 | Sonosite, Inc. SonoSite TEE, 8-3 MHz Transducer labeled: "Tee Transducer... SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021".
The TEE/8-3 MHz Transducer is designed for 2D, M Mode, color Doppler, pulse wave (P Terminated |
IYO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.