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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 K160899
Device Name CoVa Monitoring System 2
Applicant
TOSENSE, INC.
4225 EXECUTIVE SQUARE
SUITE 570
la jolla,  CA  92037
Applicant Contact susan pede
Correspondent
TOSENSE, INC.
4225 EXECUTIVE SQUARE
SUITE 570
la jolla,  CA  92037
Correspondent Contact susan pede
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DSB   FLL  
Date Received04/01/2016
Decision Date 06/22/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Clinical Trials NCT02337790
NCT02719301
Reviewed by Third Party No
Combination Product No
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