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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
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