Optina Diagnostics is one of 208 FDA 510(k) medical device manufacturers from Canada in the dataset, ranked by real submission volume.
Optina Diagnostics - FDA 510(k) Cleared Devices
Recent clearances: Mydriatic Hyperspectral Retinal Camera (MHRC-C1)
1
Total
1
Cleared
0
Denied
Optina Diagnostics has 1 FDA 510(k) cleared medical devices. Based in Montreal, CA.
Historical record: 1 cleared submissions from 2020 to 2020. Primary specialty: Ophthalmic.
Browse the FDA 510(k) cleared devices submitted by Optina Diagnostics Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by CardioMed Device Consultants, LLC as regulatory consultant.
FDA 510(k) Regulatory Record - Optina Diagnostics
1 devices