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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 software for optical camera-based measurement of pulse rate, heart rate, breathing rate, and/or respiratory rate
De Novo Number DEN200019
Device Name Oxehealth Vital Signs
Oxehealth Limited
magdalen center north, the oxford science park
oxford,  GB ox4 4ga
Contact hugh lloyd-jukes
Regulation Number870.2785
Classification Product Code
Date Received03/27/2020
Decision Date 03/26/2021
Decision granted (DENG)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Direct