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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 K180472
Device Name ViSi Mobile Monitoring System
Applicant
Sotera Wireless, Inc.
10020 Huenneckens St.
San Diego,  CA  92121
Applicant Contact Lan Herrington
Correspondent
Sotera Wireless, Inc.
10020 Huenneckens St.
San Diego,  CA  92121
Correspondent Contact Frank Pokrop
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSI   DXN   FLL  
Date Received02/22/2018
Decision Date 06/19/2018
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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