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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 K142087
Device Name COVA MONITORING SYSTEM
Applicant
toSense, Inc.
4225 EXECUTIVE SQUARE, SUITE 570
LA JOLLA,  CA  92037
Applicant Contact NANDINI MIRTHY
Correspondent
toSense, Inc.
4225 EXECUTIVE SQUARE, SUITE 570
LA JOLLA,  CA  92037
Correspondent Contact NANDINI MIRTHY
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Code
DSB  
Date Received07/30/2014
Decision Date 05/01/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT02048436
NCT02140905
NCT02190877
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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