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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 K883865
Device Name EXTERNAL JET SYNCHRONIZER, MODEL AMS-1010
Applicant
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Applicant Contact AJAI P SINGH
Correspondent
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Correspondent Contact AJAI P SINGH
Regulation Number868.5895
Classification Product Code
CBK  
Date Received09/13/1988
Decision Date 06/08/1989
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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