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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph Software For Over-The-Counter Use
510(k) Number K221774
Device Name Garmin ECG App
Applicant
Garmin International, Inc.
1200 E. 151st St.
Olathe,  KS  66062
Applicant Contact Travis Johnson
Correspondent
Garmin International, Inc.
1200 E. 151st St.
Olathe,  KS  66062
Correspondent Contact Travis Johnson
Regulation Number870.2345
Classification Product Code
QDA  
Date Received06/21/2022
Decision Date 01/12/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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