NAVIGATOR APPLICATIONS SUITE

Gas-machine, Anesthesia

GE HEALTHCARE FINLAND OY

The following data is part of a premarket notification filed by Ge Healthcare Finland Oy with the FDA for Navigator Applications Suite.

Pre-market Notification Details

Device IDK083098
510k NumberK083098
Device Name:NAVIGATOR APPLICATIONS SUITE
ClassificationGas-machine, Anesthesia
Applicant GE HEALTHCARE FINLAND OY 3030 OHMEDA DRIVE PO BOX 7550 Madison,  WI  53707 -7550
ContactAdrienne Lenz
CorrespondentAdrienne Lenz
GE HEALTHCARE FINLAND OY 3030 OHMEDA DRIVE PO BOX 7550 Madison,  WI  53707 -7550
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-10-17
Decision Date2009-04-01
Summary:summary

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