510(k) K961073 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
ATLAS 2.0 & HITACHI 2.0 (A TRADE NAME SUBJECT TO CHANGE)
| Applicant | Atlantis Diagnostics Intl., Inc., Bothell WA, US |
| Decision | Substantially Equivalent, Feb 19, 1997 |
| Received | Mar 18, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961073
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.