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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K252839
Device Name ZywieZ3 Sensor & Adhesive
Applicant
Zywie, Inc.
12000 Findley Rd., St. 360
Johns Creek,  GA  30097
Applicant Contact Latha Ganeshan
Correspondent
Zywie, Inc.
12000 Findley Rd., St. 360
Johns Creek,  GA  30097
Correspondent Contact Latha Ganeshan
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received09/05/2025
Decision Date 06/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Clinical Trials NCT07188129
NCT07200232
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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