510(k) K043455 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Medison Co., Ltd., Corinth TX, US |
| Decision | Substantially Equivalent, Dec 21, 2004 |
| Received | Dec 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043455
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.