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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 K123556
Device Name MORTARA SURVEYOR PATIENT MONITOR
Applicant
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Applicant Contact AMY YANG
Correspondent
MORTARA INSTRUMENT, INC.
7865 NORTH 86TH ST.
MILWAUKEE,  WI  53224
Correspondent Contact AMY YANG
Regulation Number870.1025
Classification Product Code
MHX  
Date Received11/19/2012
Decision Date 03/22/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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