510(k) K950983 ยท ERA Otoscope
IMEDGE DIGITA OTOSCOPE OR DIGITAL VIDEO OTOSCOPE
| Applicant | Introspect, Inc., Excelsior MN, US |
| Decision | Substantially Equivalent, Apr 12, 1995 |
| Received | Mar 3, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950983
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.