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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 K884150
Device Name MODIFIED CONCHATHERM III CONTROLLED HEATER
Applicant
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact WILLIAM H MURPHY
Correspondent
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact WILLIAM H MURPHY
Regulation Number868.5450
Classification Product Code
BTT  
Date Received10/03/1988
Decision Date 11/21/1988
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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