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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 K173765
Device Name Surveyor Patient Monitor
Applicant
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee,  WI  53224
Applicant Contact Manisha Gokuli
Correspondent
Mortara Instrument, Inc.
7865 North 86th Street
Milwaukee,  WI  53224
Correspondent Contact Manisha Gokuli
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DPS   DQA   DSB   DSI   DSJ  
MLD   MSX  
Date Received12/11/2017
Decision Date 09/04/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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