EEG-acp— 510(k) K212325

Substantially Equivalent

Somnomedics GmbH

FDA 510(k) clearance K212325 for EEG-acp, Substantially Equivalent on 2022-06-15. Applicant: Somnomedics GmbH.

Clearance details

Applicant: Somnomedics GmbH
Product code: Code GYB
Advisory panel: Neurology
Date received: 2021-07-26
Decision date: 2022-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Randersacker, DE

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.