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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 K102471
Device Name AS3700 ANESTHSIA DELIVERY SYSTEM
Applicant
MINDRAY DS USA, INC.
800 MACARTHUR BLVD
MAHWAH,  NJ  07430
Applicant Contact RUSSELL OLSEN
Correspondent
MINDRAY DS USA, INC.
800 MACARTHUR BLVD
MAHWAH,  NJ  07430
Correspondent Contact RUSSELL OLSEN
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/30/2010
Decision Date 02/11/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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