510(k) K002185 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SONOACE SA 9900 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Medison America, Inc., San Leandro CA, US |
| Decision | Substantially Equivalent, Aug 1, 2000 |
| Received | Jul 19, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002185
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 5, 2004 | Philips Ultrasound, Inc. HDI 4000 Ultrasound System & the Philips 4000 Ultrasound System (same system). Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.