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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 K233864
Device Name ASSURE Wearable ECG
Applicant
Kestra Medical Technologies, Inc.
3933 Lake Washington Blvd. NE
Suite 200
Kirkland,  WA  98033
Applicant Contact Beverly Magrane
Correspondent
Kestra Medical Technologies, Inc.
3933 Lake Washington Blvd. NE
Suite 200
Kirkland,  WA  98033
Correspondent Contact Jay Wiese
Regulation Number870.2800
Classification Product Code
MWJ  
Subsequent Product Code
DXH  
Date Received12/06/2023
Decision Date 05/07/2024
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		 No
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