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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Humidifier, Respiratory Gas, (Direct Patient Interface)
510(k) Number K863955
Device Name COLBY LEVEL ALARM
Applicant
Respiratory Care, Inc.
900 W. University
Arlington Heights,  IL  60004
Applicant Contact PHYLLIS PIET-HUGHES
Correspondent
Respiratory Care, Inc.
900 W. University
Arlington Heights,  IL  60004
Correspondent Contact PHYLLIS PIET-HUGHES
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/10/1986
Decision Date 11/07/1986
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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