510(k) K941659 ยท ERA Otoscope
AURAL-CAM, VIDEO EAR, VID RX
| Applicant | Gracefully Yours, Inc., Largo FL, US |
| Decision | Substantially Equivalent, Apr 26, 1994 |
| Received | Apr 5, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941659
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.