SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8

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

PHILIPS MEDICAL SYSTESMS

The following data is part of a premarket notification filed by Philips Medical Systesms with the FDA for Suresigns Vm Series Patient Monitors, Suresigns Vm4, Suresigns Vm6, And Suresigns Vm8.

Pre-market Notification Details

Device IDK103652
510k NumberK103652
Device Name:SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTESMS 300 MINUTEMAN ROAD Andover,  MA  01810 -1099
ContactLawrence Milana
CorrespondentLawrence Milana
PHILIPS MEDICAL SYSTESMS 300 MINUTEMAN ROAD Andover,  MA  01810 -1099
Product CodeMHX  
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-12-14
Decision Date2011-01-13
Summary:summary

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