DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3

System, Network And Communication, Physiological Monitors

GE HEALTHCARE

The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Datex-ohmeda Network And Icentral '05, Sales Revision 4.3.

Pre-market Notification Details

Device IDK052972
510k NumberK052972
Device Name:DATEX-OHMEDA NETWORK AND ICENTRAL '05, SALES REVISION 4.3
ClassificationSystem, Network And Communication, Physiological Monitors
Applicant GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
ContactJoel Kent
CorrespondentJoel Kent
GE HEALTHCARE 86 PILGRIM ROAD Needham,  MA  02492
Product CodeMSX  
CFR Regulation Number870.2300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-10-24
Decision Date2005-12-29
Summary:summary

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