WAVi SCAN EEG System And Accessories

Full-montage Standard Electroencephalograph

WAVi Co.

The following data is part of a premarket notification filed by Wavi Co. with the FDA for Wavi Scan Eeg System And Accessories.

Pre-market Notification Details

Device IDK213900
510k NumberK213900
Device Name:WAVi SCAN EEG System And Accessories
ClassificationFull-montage Standard Electroencephalograph
Applicant WAVi Co. 3459 Ringsby Ct. Ste. #305 Denver,  CO  80216
ContactDavid Oakley
CorrespondentDavid Jones
WAVi Co. 3459 Ringsby Ct. Ste. #305 Denver,  CO  80216
Product CodeGWQ  
CFR Regulation Number882.1400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-12-14
Decision Date2022-05-06

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