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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 K120075
Device Name AM-6000 ANESTHESIA MACHINE
Original Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 west 20 st
hialeah,  FL  33010
Original Contact jorge millan
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received01/10/2012
Decision Date 01/26/2012
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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