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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name home monitoring ophthalmic optical coherence tomography (oct) imaging device
De Novo Number DEN230043
Device Name Notal Vision Home Optical Coherence Tomography (OCT) System
Requester
notal vision inc
7717 coppermine drive
manassas,  VA  20109
Contact kester nahen
Regulation Number886.1600
Classification Product Code
SAX  
Date Received06/07/2023
Decision Date 05/15/2024
Decision granted (DENG)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
Predetermined Change
Control Plan Authorized		 No
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