M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0

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 M3290b Intellivue Information Center Software, Release A.0.

Pre-market Notification Details

Device IDK102495
510k NumberK102495
Device Name:M3290B INTELLIVUE INFORMATION CENTER SOFTWARE, RELEASE A.0
ClassificationMonitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMEN RD. Andover,  MA  01810 -1099
ContactTheresa Poole
CorrespondentTheresa Poole
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMEN RD. Andover,  MA  01810 -1099
Product CodeMHX  
Subsequent Product CodeDSH
Subsequent Product CodeDSI
Subsequent Product CodeMLD
Subsequent Product CodeMSX
CFR Regulation Number870.1025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-08-31
Decision Date2010-09-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838083684 K102495 000
00884838029620 K102495 000

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