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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Adjunctive Epicardial Vascular Physiologic Status Indicator
510(k) Number K231335
Device Name Cleerly ISCHEMIA
Applicant
Cleerly, Inc
110 16th Steet Suite 1400 #104
Denver,  CO  80218
Applicant Contact Candice Bautista-Biddle
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number870.2200
Classification Product Code
QXZ  
Date Received05/08/2023
Decision Date 09/08/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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