EEG-acp
FDA 510(k) K212325 · Somnomedics GmbH
510(k) numberK212325
Submission
- Device name
- EEG-acp
- Applicant
- Somnomedics GmbH
Randersacker, DE - Received
- July 26, 2021
- Decision date
- June 15, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was EEG-acp cleared by the FDA?
EEG-acp (K212325) received a 510(k) decision of Substantially Equivalent on June 15, 2022, 324 days after the submission was received.
What is the product code of K212325?
The FDA product code is GYB – Media, Electroconductive, a Class II (moderate risk) device regulated under 21 CFR 882.1275.