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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 K260066
Device Name PanopticAI Vital Signs (1.6.1-22)
Applicant
PanopticAI Technologies Limited
Rm. A, Ground Floor, 3 Tin Hau Temple Rd.
North Pt.
Hong Kong,  HK
Applicant Contact Nick Chin
Correspondent
Vee Care (Asia) Limited
Flat A & B, 17f Chung Pont Commercial Bldg.
300 Hennessy Rd., Wanchai
Hong Kong,  HK
Correspondent Contact Evie Chen
Regulation Number870.2785
Classification Product Code
QME  
Subsequent Product Codes
BZQ   CCK   DPZ   DQA   DXN  
FLL   MWI  
Date Received01/09/2026
Decision Date 05/21/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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