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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 K880448
Device Name CERION OXY THRESHOLD ALARM
Applicant
Ceramatec, Inc.
2425 S. 900 W.
Salt Lake City,  UT  84119
Applicant Contact MARK HASLAM
Correspondent
Ceramatec, Inc.
2425 S. 900 W.
Salt Lake City,  UT  84119
Correspondent Contact MARK HASLAM
Regulation Number868.1720
Classification Product Code
CCL  
Date Received02/02/1988
Decision Date 03/21/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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