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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)
510(k) Number K120631
Device Name PATIENT 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 Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRT   DSA   DSF   DSK   DXN  
FLL   MLD  
Date Received03/01/2012
Decision Date 05/25/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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