Cleared Traditional

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)

K240575 · Eemagine Medical Imaging Solutions GmbH · Neurology

Nov 2024

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K240575 is an FDA 510(k) clearance for the WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281), a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Eemagine Medical Imaging Solutions GmbH (Berlin, DE). The FDA issued a Cleared decision on November 25, 2024, 269 days after receiving the submission on March 1, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number	K240575 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2024
Decision Date	November 25, 2024
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Neurology (NE)
Summary	Summary PDF