Maxxi Position Sensor

Full-montage Standard Electroencephalograph

Neurovirtual USA, INC.

The following data is part of a premarket notification filed by Neurovirtual Usa, Inc. with the FDA for Maxxi Position Sensor.

Pre-market Notification Details

Device IDK191492
510k NumberK191492
Device Name:Maxxi Position Sensor
ClassificationFull-montage Standard Electroencephalograph
Applicant Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale,  FL  33309
ContactEduardo Faria
CorrespondentEduardo Faria
Neurovirtual USA, INC. 3303 W Commercial Blvd #100 Fort Lauderdale,  FL  33309
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-05
Decision Date2020-04-24

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