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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name humidifier, respiratory gas, (direct patient interface)
510(k) Number K863154
Device Name HEATED JET HUMIDIFIER MODEL AMS-1020
Applicant
ACUTRONIC MEDICAL SYSTEMS AG
KREUZSTRASSE 100
JONA-RAPPER SWRIL,  CH 8645
Applicant Contact AJAI SINGH
Correspondent
ACUTRONIC MEDICAL SYSTEMS AG
KREUZSTRASSE 100
JONA-RAPPER SWRIL,  CH 8645
Correspondent Contact AJAI SINGH
Regulation Number868.5450
Classification Product Code
BTT  
Date Received08/15/1986
Decision Date 01/12/1987
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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