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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Cardiovascular Status Indicator
510(k) Number K252204
Device Name prolaio eVO2peak Module (Version 1.0)
Applicant
Prolaio, Inc.
230 W Monroe, Unit 2560
Chicago,  IL  60606
Applicant Contact George Allen Hides
Correspondent
Prolaio, Inc.
230 W Monroe, Unit 2560
Chicago,  IL  60606
Correspondent Contact George Allen Hides
Regulation Number870.2200
Classification Product Code
PPW  
Date Received07/14/2025
Decision Date 12/16/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT05678530
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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