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 the device name listed in this FDA 510(k) record. The listed applicant is Somnomedics GmbH. It received FDA 510(k) clearance on 2022-06-15 under 510(k) 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. The listed applicant is Somnomedics GmbH. The 510(k) number is K212325.

When did EEG-acp receive FDA 510(k) clearance?

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

Who is the listed applicant for EEG-acp?

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

What is the FDA product code for EEG-acp?

The FDA product code for EEG-acp is GYB.

Other records listing Somnomedics GmbH as applicant

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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.