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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
Device Name INTELLISAVE AX700 ANESTHESIA SYSTEM
Applicant
PHILIPS ANESTHESIA CARE
ISLEVDALVEJ 211
RODOVRE,  DK 2610
Applicant Contact NEIL BATTISTE
Correspondent
PHILIPS ANESTHESIA CARE
ISLEVDALVEJ 211
RODOVRE,  DK 2610
Correspondent Contact NEIL BATTISTE
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received07/13/2012
Decision Date 08/02/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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