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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Airway Pressure (Includes Gauge And/Or Alarm)
510(k) Number K936009
Device Name AMS 3000M
Applicant
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Applicant Contact TRUDI KELLER
Correspondent
Acutronic Medical Systems AG
Kreuzstrasse 100
Jona-Rapper Swril,  CH 8645
Correspondent Contact TRUDI KELLER
Regulation Number868.2600
Classification Product Code
CAP  
Date Received12/16/1993
Decision Date 05/03/1995
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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