510(k) K093495 ยท HLJ Ophthalmoscope, Battery-Powered
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS
| Applicant | American Diagnostic Corp., Hauppauge NY, US |
| Decision | Substantially Equivalent, Nov 19, 2010 |
| Received | Nov 10, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K093495
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.