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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 K253650
Device Name Anura Mobile Core SDK (M1)
Applicant
Nuralogix Corporation
250 University Ave.
Suite 209
Toronto,  CA M5H3E5
Applicant Contact Jessica Mavadia-Shukla
Correspondent
Nuralogix Corporation
250 University Ave.
Suite 209
Toronto,  CA M5H3E5
Correspondent Contact Jessica Mavadia-Shukla
Regulation Number870.2785
Classification Product Code
QME  
Subsequent Product Code
BZQ  
Date Received11/20/2025
Decision Date 06/11/2026
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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