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FDA 510(k)

WAVEGUARD (TM) EEG CAP

K-Number: K110223 · 2011-06-29

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2011-06-29
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

WAVEGUARD (TM) EEG CAP 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 2011-06-29 under 510(k) number K110223. 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 (TM) EEG CAP?

WAVEGUARD (TM) EEG CAP is a medical device that received FDA 510(k) clearance on 2011-06-29. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K110223.

When did WAVEGUARD (TM) EEG CAP receive FDA 510(k) clearance?

WAVEGUARD (TM) EEG CAP received FDA 510(k) clearance on 2011-06-29, under 510(k) number K110223.

Who is the listed applicant for WAVEGUARD (TM) EEG CAP?

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 (TM) EEG CAP?

The FDA product code for WAVEGUARD (TM) EEG CAP is GXY.

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Other records listing Eemagine Medical Imaging Solutions GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240575WaveGuard Net EEG Cap (NA-245, NA-255, NA-261, NA-265, NA-271, NA-281)K210109visor2 systemK192889NeoK172312eego amplifiersK070358MAXINSIGHTK051825COGNITRACE

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Related Devices (Code: GXY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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