Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

WAVi SCAN EEG System and Accessories

K-Number: K213900 · 2022-05-06

ApplicantWavi Co.
Decision Date2022-05-06
Product CodeGWQ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WAVi SCAN EEG System and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Wavi Co.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) 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. The listed applicant is Wavi Co.. The 510(k) number is K213900.

When did WAVi SCAN EEG System and Accessories receive FDA 510(k) clearance?

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

Who is the listed applicant for WAVi SCAN EEG System and Accessories?

The FDA 510(k) record lists Wavi Co. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Wavi Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162460WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts

Related Devices (Code: GWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261604Enobio Dx (Enobio Dx 8);Enobio Dx (Enobio Dx 20);Enobio Dx (Enobio Dx 32)Neuroelectrics Barcelona S.L.U.K260455New Wave SystemZeto, Inc.K233403Flexset SystemZeto, Inc.K231366Neuronaute PlusBioserenity SasK221959Q21Neurofield, Inc.K231457SPARK ScanSpark Neuro, Inc.

Official Source

View on FDA Database →

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

↑