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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K191692
Device Name KardioScreen
Applicant
iMedrix Inc. (formerly Piitech Inc.)
1525 McCarthy Blvd., Suite 1059
Milpitas,  CA  95035
Applicant Contact Srikanth Jadcherla
Correspondent
iMedrix Inc. (formerly Piitech Inc.)
1525 McCarthy Blvd., Suite 1059
Milpitas,  CA  95035
Correspondent Contact Srikanth Jadcherla
Regulation Number870.2340
Classification Product Code
DPS  
Date Received06/25/2019
Decision Date 01/10/2020
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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