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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 K012693
Device Name MISTRAL CRITICAL CARE JET VENTILATOR AND ACCESSORIES
Applicant
ACUTRONIC MEDICAL SYSTEMS AG
PO BOX 85820
TUCSON,  AZ  85754 -5820
Applicant Contact TERRY TORZALA
Correspondent
ACUTRONIC MEDICAL SYSTEMS AG
PO BOX 85820
TUCSON,  AZ  85754 -5820
Correspondent Contact TERRY TORZALA
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/14/2001
Decision Date 08/01/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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