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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 K900744
Device Name AMS 3000 PORTABLE JET VENTILATOR
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 Received02/16/1990
Decision Date 04/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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