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FDA 510(k)

8-CH Electroencephalography Amplifier

K-Number: K201747 · 2020-12-27

ApplicantHipposcreen Neurotech Corp.
Decision Date2020-12-27
Product CodeGWL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

8-CH Electroencephalography Amplifier is a medical device manufactured by Hipposcreen Neurotech Corp.. It received FDA 510(k) clearance on 2020-12-27 under approval number K201747. The device is classified under product code GWL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 8-CH Electroencephalography Amplifier?

8-CH Electroencephalography Amplifier is a medical device that received FDA 510(k) clearance on 2020-12-27. It is manufactured by Hipposcreen Neurotech Corp.. The 510(k) number is K201747.

When was 8-CH Electroencephalography Amplifier approved by the FDA?

8-CH Electroencephalography Amplifier received FDA 510(k) clearance on 2020-12-27, under approval number K201747.

What company makes 8-CH Electroencephalography Amplifier?

8-CH Electroencephalography Amplifier is manufactured by Hipposcreen Neurotech Corp..

What is the FDA product code for 8-CH Electroencephalography Amplifier?

The FDA product code for 8-CH Electroencephalography Amplifier is GWL.

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Official Source

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