FDA 510(k) Application Details - K221774

Device Classification Name	More FDA Info for this Device
510(K) Number	K221774
Device Name	Garmin ECG App
Applicant	Garmin International, Inc. 1200 East 151st Street Olathe, KS 66062 US Other 510(k) Applications for this Company
Contact	Travis Johnson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QDA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2022
Decision Date	01/12/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review