510(k) K031391 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
HF MODULE WITH TRANSDUCERS
| Applicant | Ophthalmic Technologies, Inc., Hasbrouck NJ, US |
| Decision | Substantially Equivalent, Jun 20, 2003 |
| Received | May 2, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K031391
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.