PATIENT MONITORS VARIOUS MODELS

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 Patient Monitors Various Models.

Pre-market Notification Details

Device IDK151812
510k NumberK151812
Device Name:PATIENT MONITORS VARIOUS MODELS
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover,  MA  03104 -1099
ContactMary Kruitwagen
CorrespondentMary Kruitwagen
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN ROAD Andover,  MA  03104 -1099
Product CodeMHX  
Subsequent Product CodeDQA
Subsequent Product CodeDXQ
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-07-02
Decision Date2016-01-26
Summary:summary

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