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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name detector and alarm, arrhythmia
510(k) Number K230265
Device Name MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection System
Applicant
InfoBionic, Inc.
312 Billerica Rd. Office Link #5
Chelmsford,  MA  02184
Applicant Contact Dave MacCutcheon
Correspondent
MethodSense, Inc.
1 Copley Pkwy, Suite 410
Morrisville,  NC  27560
Correspondent Contact Rita King
Regulation Number870.1025
Classification Product Code
DSI  
Date Received01/31/2023
Decision Date 10/06/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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