MX40 Release B.07

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

Philips Medical Systems

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Mx40 Release B.07.

Pre-market Notification Details

Device IDK172226
510k NumberK172226
Device Name:MX40 Release B.07
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant Philips Medical Systems 3000 Minuteman Road Andover,  MA  01810
ContactTheresa Poole
CorrespondentTheresa Poole
Philips Medical Systems 3000 Minuteman Road Andover,  MA  01810
Product CodeMHX  
Subsequent Product CodeDQA
Subsequent Product CodeDRG
Subsequent Product CodeDRW
Subsequent Product CodeDSA
Subsequent Product CodeDSI
Subsequent Product CodeMLD
Subsequent Product CodeMSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-07-25
Decision Date2017-11-09
Summary:summary

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