510(k) K974522 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
3D I-SCAN
| Applicant | Ophthalmic Technologies, Inc., Hasbrouck NJ, US |
| Decision | Substantially Equivalent, Feb 25, 1998 |
| Received | Dec 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974522
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.