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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 K220899
Device Name Oxehealth Vital Signs
Applicant
Oxehealth Limited
Magdalen Centre North, The Oxford Science Park
Oxford,  GB OX4 4GA
Applicant Contact Iain Charlton
Correspondent
Oxehealth Limited
Magdalen Centre North, The Oxford Science Park
Oxford,  GB OX4 4GA
Correspondent Contact Iain Charlton
Regulation Number870.2785
Classification Product Code
QME  
Date Received03/28/2022
Decision Date 04/29/2022
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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