Cleared Traditional

EEG-acp

K212325 · Somnomedics GmbH · Neurology
Jun 2022
Decision
324d
Days
Class 2
Risk

About This 510(k) Submission

K212325 is an FDA 510(k) clearance for the EEG-acp, a Media, Electroconductive (Class II — Special Controls, product code GYB), submitted by Somnomedics GmbH (Randersacker, DE). The FDA issued a Cleared decision on June 15, 2022, 324 days after receiving the submission on July 26, 2021. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1275.

Submission Details

510(k) Number K212325 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2021
Decision Date June 15, 2022
Days to Decision 324 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GYB — Media, Electroconductive
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1275

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