PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441

System, Network And Communication, Physiological Monitors

PHILIPS MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Philips Medical Systems with the FDA for Philips Telemedicine Server/system, Model 861441.

Pre-market Notification Details

Device IDK091176
510k NumberK091176
Device Name:PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. M/S 0220 Andover,  MA  01810
ContactPaul Schrader
CorrespondentPaul Schrader
PHILIPS MEDICAL SYSTEMS 3000 MINUTEMAN RD. M/S 0220 Andover,  MA  01810
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-22
Decision Date2009-11-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884838041530 K091176 000
00884838040878 K091176 000
00884838040861 K091176 000

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