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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 a medical device manufactured by Medeia, Inc.. It received FDA 510(k) clearance on 2023-01-28 under approval 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. It is manufactured by Medeia, Inc.. The 510(k) number is K212684.

When was BrainView QEEG Software approved by the FDA?

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

What company makes BrainView QEEG Software?

BrainView QEEG Software is manufactured by Medeia, Inc..

What is the FDA product code for BrainView QEEG Software?

The FDA product code for BrainView QEEG Software is OLU.

Other Devices by Medeia, Inc.

Related Devices (Code: OLU)

Official Source

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