510(k) K012080 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
SSD-5000 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Aloka Co., Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 29, 2001 |
| Received | Jul 3, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012080
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.