510(k) K053069 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOSITE MICROMAXX DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES)
| Applicant | Sonosite,Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Nov 16, 2005 |
| Received | Nov 1, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053069
| 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 |
| Mar 29, 2007 | Sonosite, Inc. MicroMaxx LAP/12-5 MHz Transducer, Laparoscopic Ultrasound Transducer Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.