510(k) K123821 ยท ERA Otoscope
AIO HD OTOSCOPE
| Applicant | Blue Focus, Lawrenceville GA, US |
| Decision | Substantially Equivalent, May 17, 2013 |
| Received | Dec 12, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123821
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.