510(k) K042885 ยท HLI Ophthalmoscope, Ac-Powered
OCT-OPTHALMOSCOPE
| Applicant | Ophthalmic Technologies, Inc., Hasbrouck NJ, US |
| Decision | Substantially Equivalent, Jan 21, 2005 |
| Received | Oct 19, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042885
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.