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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Electrocardiograph, Telephone
510(k) Number K250233
Device Name PreemptiveAI Clinical SDK
Applicant
Measure Labs, Inc. (Dba Preemptiveai, Inc.)
2101 N 34th St.
Suite 195
Seattle,  WA  98103
Applicant Contact Matt Whitehill
Correspondent
RQM+
2101 N 34th St.
Suite 195
Seattle,  WA  98103
Correspondent Contact Matt Whitehill
Regulation Number870.2920
Classification Product Code
DXH  
Date Received01/27/2025
Decision Date 02/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06696339
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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