Natus VikingQuest

Electromyograph, Diagnostic

Natus Neurology Incorporated

The following data is part of a premarket notification filed by Natus Neurology Incorporated with the FDA for Natus Vikingquest.

Pre-market Notification Details

Device IDK172743
510k NumberK172743
Device Name:Natus VikingQuest
ClassificationElectromyograph, Diagnostic
Applicant Natus Neurology Incorporated 3150 Pleasant View Road Middleteon,  WI  53562
ContactShane T. Sawall
CorrespondentShane T. Sawall
Natus Neurology Incorporated 3150 Pleasant View Road Middleteon,  WI  53562
Product CodeIKN  
Subsequent Product CodeGWE
Subsequent Product CodeGWF
Subsequent Product CodeGWJ
Subsequent Product CodeGZP
Subsequent Product CodeJXE
Subsequent Product CodeOLT
CFR Regulation Number890.1375 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-12
Decision Date2017-12-19
Summary:summary

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