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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 K243687
Device Name Vital Signs
Applicant
Oxehealth Limited
Bee House, 140 Eastern Ave.
Milton Park
Abingdon,  GB OX14 4SB
Applicant Contact John Kemeny
Correspondent
Oxehealth Limited
Bee House, 140 Eastern Ave.
Milton Park
Abingdon,  GB OX14 4SB
Correspondent Contact John Kemeny
Regulation Number870.2785
Classification Product Code
QME  
Date Received11/29/2024
Decision Date 08/27/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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