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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate
510(k) Number K211906
Device Name Vital Signs
Applicant
Oxehealth Limited
Magdalen Centre N., The Oxford Science Park
Oxford,  GB OX4 4GA
Applicant Contact Hugh Lloyd-Jukes
Correspondent
Oxehealth Limited
Magdalen Centre N., The Oxford Science Park
Oxford,  GB OX4 4GA
Correspondent Contact Hugh Lloyd-Jukes
Regulation Number870.2785
Classification Product Code
QME  
Date Received06/21/2021
Decision Date 07/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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