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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 K232035
Device Name Impala
Applicant
AliveCor, Inc.
189 N. Bernardo Ave.
Mountain View,  CA  94043
Applicant Contact Samip Shah
Correspondent
MDQR, LLC.
1790 Montemar Way
San Jose,  CA  95125
Correspondent Contact Prabhu Raghavan
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/07/2023
Decision Date 06/07/2024
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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