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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 K841295
Device Name HYPOTHERMIA OXYGEN WARMER-TREATMENT SYS
Applicant
BOW/PARM
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
BOW/PARM
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number868.5450
Classification Product Code
BTT  
Date Received03/29/1984
Decision Date 08/08/1984
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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