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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 K183638
Device Name SmartLinx Vitals Plus Patient Monitoring System
Applicant
Capsule Technologie
300 Brickstone Square Suite 203
Andover,  MA  01810
Applicant Contact Maylin Truesdell
Correspondent
Capsule Technologie
300 Brickstone Square Suite 203
Andover,  MA  01810
Correspondent Contact Maylin Truesdell
Regulation Number870.2300
Classification Product Code
MWI  
Subsequent Product Codes
DQA   DXN   FLL  
Date Received12/26/2018
Decision Date 04/17/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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