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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Carbon-Dioxide, Cutaneous
510(k) Number K151329
Device Name SenTec Digital Monitor, OxiVenT Sensor, V-Sign Sensor, Staysite Adhesive Pad, V-STATS PC Software including V-CareNet
Applicant
Sentec AG
Ringstrasse 39
Therwil,  CH 4106
Applicant Contact ANKE WEISBRICH
Correspondent
Imagenix, Inc.
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Codes
DPZ   KLK   LPP  
Date Received05/18/2015
Decision Date 12/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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