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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 K853146
Device Name RESPIR THER HUMID CONTAIN STERILE WATER FOR USP
Applicant
Automatic Liquid Packaging, Inc.
2200 W. Lake Shore Dr.
Woodstock,  IL  60098
Applicant Contact FRANK LEO
Correspondent
Automatic Liquid Packaging, Inc.
2200 W. Lake Shore Dr.
Woodstock,  IL  60098
Correspondent Contact FRANK LEO
Regulation Number868.5450
Classification Product Code
BTT  
Date Received07/29/1985
Decision Date 08/06/1985
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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