Surveyor Patient Monitor

Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

Mortara Instrument, Inc.

The following data is part of a premarket notification filed by Mortara Instrument, Inc. with the FDA for Surveyor Patient Monitor.

Pre-market Notification Details

Device IDK173765
510k NumberK173765
Device Name:Surveyor Patient Monitor
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Mortara Instrument, Inc. 7865 North 86th Street Milwaukee,  WI  53224
ContactManisha Gokuli
CorrespondentManisha Gokuli
Mortara Instrument, Inc. 7865 North 86th Street Milwaukee,  WI  53224
Product CodeMHX  
Subsequent Product CodeDPS
Subsequent Product CodeDQA
Subsequent Product CodeDSB
Subsequent Product CodeDSI
Subsequent Product CodeDSJ
Subsequent Product CodeMLD
Subsequent Product CodeMSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-12-11
Decision Date2018-09-04
Summary:summary

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