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FDA 510(k)

BrainView QEEG Software

K-Number: K212684 · 2023-01-28

ApplicantMedeia, Inc.
Decision Date2023-01-28
Product CodeOLU
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

BrainView QEEG Software is the device name listed in this FDA 510(k) record. The listed applicant is Medeia, Inc.. It received FDA 510(k) clearance on 2023-01-28 under 510(k) number K212684. The device is classified under product code OLU. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BrainView QEEG Software?

BrainView QEEG Software is a medical device that received FDA 510(k) clearance on 2023-01-28. The listed applicant is Medeia, Inc.. The 510(k) number is K212684.

When did BrainView QEEG Software receive FDA 510(k) clearance?

BrainView QEEG Software received FDA 510(k) clearance on 2023-01-28, under 510(k) number K212684.

Who is the listed applicant for BrainView QEEG Software?

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

What is the FDA product code for BrainView QEEG Software?

The FDA product code for BrainView QEEG Software is OLU.

Other records listing Medeia, Inc. 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.

K192753NeuralScan SystemK191266VitalScan ANS

Related Devices (Code: OLU)

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.

K253015Cognitive Function Neuroimaging (cfNI) Software (1.0.0)VoxNeuro, Inc.K240420NeuroField Analysis SuiteNeurofield, Inc.K222838iSyncBrain©-CiMediSync, Inc.K202588BNA PlatformElminda, Ltd.K191432cortiQ PROG.Tec Medical Engineering GmbHK171414qEEG-ProBrainmaster Technologies, Inc.

Official Source

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