FDA 510(k)

EEG-acp

K-Number: K212325 · 2022-06-15

Decision Date2022-06-15

Product CodeGYB

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EEG-acp is a medical device manufactured by Somnomedics GmbH. It received FDA 510(k) clearance on 2022-06-15 under approval number K212325. The device is classified under product code GYB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EEG-acp?

EEG-acp is a medical device that received FDA 510(k) clearance on 2022-06-15. It is manufactured by Somnomedics GmbH. The 510(k) number is K212325.

When was EEG-acp approved by the FDA?

EEG-acp received FDA 510(k) clearance on 2022-06-15, under approval number K212325.

What company makes EEG-acp?

EEG-acp is manufactured by Somnomedics GmbH.

What is the FDA product code for EEG-acp?

The FDA product code for EEG-acp is GYB.

Other Devices by Somnomedics GmbH

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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.