FDA 510(k)

WAVi SCAN EEG System and Accessories

K-Number: K213900 · 2022-05-06

Decision Date2022-05-06

Product CodeGWQ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

WAVi SCAN EEG System and Accessories is a medical device manufactured by Wavi Co.. It received FDA 510(k) clearance on 2022-05-06 under approval number K213900. The device is classified under product code GWQ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WAVi SCAN EEG System and Accessories?

WAVi SCAN EEG System and Accessories is a medical device that received FDA 510(k) clearance on 2022-05-06. It is manufactured by Wavi Co.. The 510(k) number is K213900.

When was WAVi SCAN EEG System and Accessories approved by the FDA?

WAVi SCAN EEG System and Accessories received FDA 510(k) clearance on 2022-05-06, under approval number K213900.

What company makes WAVi SCAN EEG System and Accessories?

WAVi SCAN EEG System and Accessories is manufactured by Wavi Co..

What is the FDA product code for WAVi SCAN EEG System and Accessories?

The FDA product code for WAVi SCAN EEG System and Accessories is GWQ.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.