510(k) K082098 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOSITE MAXX SERIES ULTRASOUND SYSTEM
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Aug 25, 2008 |
| Received | Jul 25, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082098
| 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 2, 2010 | Sonosite, Inc. PowerPark is an accessory to the V or H Universal Stand and comprised of two parts: the stand mounted assembly (P12822) and a docking assembly (P12834). The stand mounted assembly is mounted to the Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.