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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Heater, Breathing System W/Wo Controller (Not Humidifier Or Nebulizer
510(k) Number K881625
Device Name CONCHATHERM III PLUS DUAL HEAT WIRE SERVO CONTROLL
Applicant
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Applicant Contact PIET-HUGHES
Correspondent
RESPIRATORY CARE, INC.
900 W. UNIVERSITY
ARLINGTON HEIGHTS,  IL  60004
Correspondent Contact PIET-HUGHES
Regulation Number868.5270
Classification Product Code
BZE  
Date Received04/12/1988
Decision Date 06/21/1988
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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