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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 K122036
Device Name VISI MOBILE MONITORING SYSTEM
Applicant
Sotera Wireless, Inc.
9444 Waples St.
Suite 280
San Diego,  CA  92121
Applicant Contact EBEN GORDON
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRT   DXN   FLL  
Date Received07/11/2012
Decision Date 08/15/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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