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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K973985
Device Name AS/3 ANAESTHESIA DELIVERY UNIT (AS/3 ADU)
Applicant
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Applicant Contact JOEL KENT
Correspondent
DATEX-ENGSTROM, INC.
2 HIGHWOOD DR.
TEWKSBURY,  MA  01876
Correspondent Contact JOEL KENT
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received10/20/1997
Decision Date 10/30/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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