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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”)
Requester
continuse biometrics ltd.
habarzel 32b
tel-aviv, IL 6971048
Contact
sagi polani
Regulation Number
870.2786
Classification Product Code
QOK
Date Received
06/12/2020
Decision Date
04/01/2021
Decision
granted (DENG)
Classification Advisory Committee
Cardiovascular
Review Advisory Committee
Cardiovascular
Classification Order
Classification Order
FDA Review
Decision Summary
Type
Direct
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