510(k) K000554 ยท IYO System, Imaging, Pulsed Echo, Ultrasonic
POCKET ULTRASONIC OPHTHALMIC PACHYMETER, BIOMETRY TRANSDUCER FOR POCKET
| Applicant | Quantel Medical, Hasbrouck Heights NJ, US |
| Decision | Substantially Equivalent, Mar 14, 2000 |
| Received | Feb 18, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K000554
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.