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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 K250078
Device Name Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)
Applicant
Mindset Medical, Inc.
12439 N 32nd St.
Phoenix,  AZ  85032
Applicant Contact Jeremy Markovich
Correspondent
Mindset Medical, Inc.
12439 N 32nd St.
Phoenix,  AZ  85032
Correspondent Contact Jeremy Markovich
Regulation Number870.2785
Classification Product Code
QME  
Date Received01/13/2025
Decision Date 05/30/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06508047
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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