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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
Predetermined Change
Control Plan Authorized		 No
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