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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transmitters And Receivers, Physiological Signal, Radiofrequency
510(k) Number K141020
Device Name SURVEYOR S4 MOBILE MONITOR
Applicant
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Applicant Contact AMY YANG
Correspondent
Mortara Instrument, Inc.
7865 N. 86th St.
Milwaukee,  WI  53224
Correspondent Contact AMY YANG
Regulation Number870.2910
Classification Product Code
DRG  
Date Received04/21/2014
Decision Date 12/03/2014
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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