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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 K123048
Device Name PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO
Applicant
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20TH STREET
HIALEAH,  FL  33010
Applicant Contact JORGE MILLAN
Correspondent
ADVANCED INSTRUMENTATIONS, INC.
601 WEST 20TH STREET
HIALEAH,  FL  33010
Correspondent Contact JORGE MILLAN
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DQA   DRT   DSA   DSI   DSK  
DXN   FLL  
Date Received09/28/2012
Decision Date 01/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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