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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 K160685
Device Name Surveyor S4 Mobile Monitor
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact Sarah Weber
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact Sarah Weber
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DPS   DQA  
Date Received03/11/2016
Decision Date 08/04/2016
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
Recalls CDRH Recalls
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