510(k) K012253 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
SSD-1000 DIAGNOSTIC ULTRASOUND SYSTEM
| Applicant | Aloka Co., Ltd., Wallingford CT, US |
| Decision | Substantially Equivalent, Aug 30, 2001 |
| Received | Jul 18, 2001 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K012253
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.