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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 K252589
Device Name Corvair Monza
Applicant
AliveCor, Inc.
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  95043
Applicant Contact Samip Shah
Correspondent
AliveCor, Inc.
189 N. Bernardo Ave.
Suite 100
Mountain View,  CA  95043
Correspondent Contact Samip Shah
Regulation Number870.1025
Classification Product Code
MHX  
Date Received08/15/2025
Decision Date 01/09/2026
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		 No
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