510(k) K012727 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HUMPHREY OCT3
| Applicant | Carl Zeiss Ophthalmic Systems, Inc., Dublin CA, US |
| Decision | Substantially Equivalent, Jan 31, 2002 |
| Received | Aug 15, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K012727
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.