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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 K223622
Device Name FaceHeart Vitals Software Development Kit (FH vitals SDK)
Applicant
FaceHeart Corp.
PO Box 309, Ugland House
Grand Cayman,  KY KY1-1104
Applicant Contact Morris Chung
Correspondent
FaceHeart Corp.
PO Box 309, Ugland House
Grand Cayman,  KY KY1-1104
Correspondent Contact Morris Chung
Regulation Number870.2785
Classification Product Code
QME  
Date Received12/05/2022
Decision Date 09/01/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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