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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
S65 W35739 PIPER ROAD
EAGLE,  WI  53119
Applicant Contact STEPHEN H GORSKI
Correspondent
SENTEC AG
S65 W35739 PIPER ROAD
EAGLE,  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
Recalls CDRH Recalls
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