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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K142827
Device Name Visi Mobile Monitoring System, Visi Mobile Chest Sensor
Applicant
Sotera Wireless, Inc.
10020 Huennekens St.
San Diego,  CA  92121
Applicant Contact Eben Gordon
Correspondent
Sotera Wireless, Inc.
10020 Huennekens St.
San Diego,  CA  92121
Correspondent Contact Eben Gordon
Regulation Number870.1025
Classification Product Code
MHX  
Date Received09/30/2014
Decision Date 07/20/2015
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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