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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 K112478
FOIA Releasable 510(k) K112478
Device Name VISI MOBILE MONITORING SYSTEM
Applicant
SOTERA WIRELESS, INC
9444 WAPLES STREET
SAN DIEGO,  CA  92121
Applicant Contact EBEN GORDON
Correspondent
SOTERA WIRELESS, INC
9444 WAPLES STREET
SAN DIEGO,  CA  92121
Correspondent Contact EBEN GORDON
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DRT   DXN   FLL  
Date Received08/29/2011
Decision Date 03/22/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00881829
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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