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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
510(k) Number K010795
Device Name CAPNOPROBE SL, MODEL 2000
Applicant
Optical Sensors, Inc.
800 Lenanger Ln.
Stoughton,  WI  53589
Applicant Contact Gary Syring
Correspondent
Optical Sensors, Inc.
800 Lenanger Ln.
Stoughton,  WI  53589
Correspondent Contact Gary Syring
Regulation Number868.1400
Classification Product Code
CCK  
Date Received03/16/2001
Decision Date 04/11/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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