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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 K240890
Device Name PanopticAI Vital Signs
Applicant
PanopticAI technologies Limited
Rm. A, Ground Floor
3 Tin Hau Temple Rd., N. Pt.
Hong Kong,  HK 0000
Applicant Contact Tsz Tai Chan
Correspondent
Vee Care (Asia) Limited
17th Chung Pont Commercial Bldg.
300 Hennessy Rd.
Hong Kong,  HK 0000
Correspondent Contact Jing Chen
Regulation Number870.2785
Classification Product Code
QME  
Date Received04/01/2024
Decision Date 12/23/2024
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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