510(k) K083254 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Aloka Co., Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Dec 19, 2008 |
| Received | Nov 4, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083254
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.