FDA 510(k)

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

Numéro K : K240575 · 2024-11-25

DemandeurEemagine Medical Imaging Solutions GmbH

Date de décision2024-11-25

Code produitGXY

Comité consultatifNE

DécisionSubstantially Equivalent

Résumé du dispositif

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is the device name listed in this FDA 510(k) record. The listed applicant is Eemagine Medical Imaging Solutions GmbH. It received FDA 510(k) clearance on 2024-11-25 under 510(k) number K240575. The device is classified under product code GXY. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is a medical device that received FDA 510(k) clearance on 2024-11-25. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K240575.

When did WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) receive FDA 510(k) clearance?

WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) received FDA 510(k) clearance on 2024-11-25, under 510(k) number K240575.

Who is the listed applicant for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

The FDA 510(k) record lists Eemagine Medical Imaging Solutions GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)?

The FDA product code for WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) is GXY.

Essais cliniques associés

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Autres dossiers indiquant Eemagine Medical Imaging Solutions GmbH en tant que demandeur

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Source officielle

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