510(k) K253176 ยท HKI Camera, Ophthalmic, Ac-Powered
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| Applicant | Beyond 700 Pty, Ltd., Castle Hill, AU |
| Decision | Substantially Equivalent, Jun 22, 2026 |
| Received | Sep 26, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K253176
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.