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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 K122063
Model AX700
Device Name INTELLISAVE AX700 ANESTHESIA SYSTEM
Original Applicant
PHILIPS ANESTHESIA CARE
islevdalvej 211
rodovre,  DA 2610
Original Contact neil battiste
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/13/2012
Decision Date 08/02/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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