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FDA 510(k)

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

K-Number: K240575 · 2024-11-25

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2024-11-25
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K240575.

When was WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281) approved by the FDA?

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 approval number K240575.

What company makes 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 manufactured by Eemagine Medical Imaging Solutions GmbH.

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.

Other Devices by Eemagine Medical Imaging Solutions GmbH

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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