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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K231010
Device Name Corvair
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 Number870.1025
Classification Product Code
MHX  
Date Received04/07/2023
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
Predetermined Change
Control Plan Authorized		 Yes
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