510(k) DEN250014 ยท SHL Ear, Nose, And Throat Image Analyzer
Tyto Insights for Eardrum Bulging Detection
| Applicant | Tyto Care , Ltd., Netanya, IL |
| Decision | Unknown, Mar 17, 2026 |
| Received | Apr 21, 2025 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN250014
No recall in the FDA data names this 510(k).
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