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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 K151071
Device Name SmartLinx Vitals Plus Patient Monitoring System
Applicant
CAPSULE TECHNOLOGIE SAS
300 BRICKSTONE SQURE, SUITE 203
ANDOVER,  MA  01810
Applicant Contact PETER KELLEY
Correspondent
CAPSULE TECHNOLOGIE SAS
300 BRICKSTONE SQURE, SUITE 203
ANDOVER,  MA  01810
Correspondent Contact PETER KELLEY
Regulation Number870.2300
Classification Product Code
MWI  
Date Received04/21/2015
Decision Date 09/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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