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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 hardware and software for optical camera-based measurement of heart rate and respiratory rate
De Novo Number DEN200038
Device Name Gili Pro BioSensor (also known as “Gili BioSensor System”)
ContinUse Biometrics Ltd.
habarzel 32b
tel-aviv,  IL 6971048
Contact sagi polani
Regulation Number870.2786
Classification Product Code
Date Received06/12/2020
Decision Date 04/01/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct