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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Hardware And Software For Optical Camera-Based Measurement Of Heart Rate And Respiratory Rate
510(k) Number K254240
Device Name Echo-2
Applicant
Neko Health AB
Svärdvägen 19
Danderyd,  SE 182 33
Applicant Contact Per Sundström
Correspondent
Healthcare Innovation Catalysts, Inc.
8024 Summer Mill Ct.
Bethesda,  MD  20817
Correspondent Contact Brittany Valdez Nava
Regulation Number870.2786
Classification Product Code
QOK  
Subsequent Product Code
DXR  
Date Received12/29/2025
Decision Date 09/22/2026
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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