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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 K984579
Device Name CAPNO PROBE A
Applicant
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Applicant Contact Gary J Syring
Correspondent
Optical Sensors, Inc.
7615 Golden Triangle Dr.,
Suite A
Eden Prairie,  MN  55344
Correspondent Contact Gary J Syring
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
CBR   KNT  
Date Received12/23/1998
Decision Date 12/21/2000
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
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