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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Continuous, Facility Use
510(k) Number K012691
Device Name MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES
Applicant
Acutronic Medical Systems AG
P.O. Box 85820
Tucson,  AZ  85754 -5820
Applicant Contact TERRY TORZALA
Correspondent
Acutronic Medical Systems AG
P.O. Box 85820
Tucson,  AZ  85754 -5820
Correspondent Contact TERRY TORZALA
Regulation Number868.5895
Classification Product Code
CBK  
Subsequent Product Code
BTT  
Date Received08/14/2001
Decision Date 12/20/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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