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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
Applicant
Advanced Instrumentations, Inc.
601 W. 20 St.
Hialeah,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
Advanced Instrumentations, Inc.
601 W. 20 St.
Hialeah,  FL  33010
Correspondent 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
Predetermined Change
Control Plan Authorized		 No
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