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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 K863155
Device Name UNIVERSAL JET VENTILATOR MODEL AMS-1000
Applicant
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Applicant Contact AJAI SINH
Correspondent
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Correspondent Contact AJAI SINH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received08/15/1986
Decision Date 09/28/1987
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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