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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K112465
Device Name VITAL SIGNS MONITOR
Applicant
ADVANCED INSTRUMENTS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
ADVANCED INSTRUMENTS, INC.
601 WEST 20 ST
HIALEAH,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number870.2700
Classification Product Code
DQA  
Subsequent Product Codes
DXN   FLL  
Date Received08/26/2011
Decision Date 09/14/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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