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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 (without arrhythmia detection or alarms)
510(k) Number K150361
Device Name ViSi Mobile Monitoring System
Applicant
Sotera Wireless, Inc.
10020 Huennekens Street
San Diego,  CA  92121
Applicant Contact Carson Krupp
Correspondent
Sotera Wireless, Inc.
10020 Huennekens Street
San Diego,  CA  92121
Correspondent Contact Carson Krupp
Regulation Number870.2300
Classification Product Code
MWI  
Date Received02/12/2015
Decision Date 04/30/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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