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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Connector, Airway (Extension)
510(k) Number K862435
Device Name DOUBLE LUMEN E T ADAPTOR
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 Number868.5810
Classification Product Code
BZA  
Date Received06/26/1986
Decision Date 10/22/1986
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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