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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 K101690
Device Name SENTEC DIGITAL MONITOR, V-SIGN SENSOR AND V-SIGN SENSOR 2 WITH DIGITAL SENSOR ADAPER CABLE
Applicant
Sentec AG
S65w35739 Piper Rd.
Egale,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
Sentec AG
S65w35739 Piper Rd.
Egale,  WI  53119
Correspondent Contact STEPHEN H GORSKI
Regulation Number868.2480
Classification Product Code
LKD  
Subsequent Product Codes
DPZ   DQA  
Date Received06/16/2010
Decision Date 12/03/2010
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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