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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
Model 0631F-01000-00
Device Name AS3700 ANESTHSIA DELIVERY SYSTEM
Original Applicant
MINDRAY DS USA, INC.
800 macarthur blvd
mahwah,  NJ  07430
Original Contact russell olsen
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/30/2010
Decision Date 02/11/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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