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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, oxygen, gaseous-phase
510(k) Number K911344
Device Name CERION HAND HELD OXYGEN ANALYZER
Original Applicant
CERAMATEC, INC.
2425 south 900 west
salt lake city,  UT  84119
Original Contact mark haslam
Regulation Number868.1720
Classification Product Code
CCL  
Date Received03/27/1991
Decision Date 06/18/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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