EEG-acp— 510(k) K212325

Clearance details

Applicant

Somnomedics GmbH

Product code

Code GYB

Device class

Class 2

Regulation

21 CFR 882.1275

Advisory panel

Neurology

Date received

2021-07-26

Decision date

2022-06-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Randersacker, DE

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