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FDA 510(k)

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG

K-Number: K002631 · 2000-10-23

ApplicantEemagine Medical Imaging Solutions GmbH
Decision Date2000-10-23
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG 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 2000-10-23 under 510(k) number K002631. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG?

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG is a medical device that received FDA 510(k) clearance on 2000-10-23. The listed applicant is Eemagine Medical Imaging Solutions GmbH. The 510(k) number is K002631.

When did ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG receive FDA 510(k) clearance?

ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG received FDA 510(k) clearance on 2000-10-23, under 510(k) number K002631.

Who is the listed applicant for ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG?

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 ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG?

The FDA product code for ELECTROENCEPHALOGRAPH SOFTWARE EEMAGINE EEG is OLX.

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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 amplifiersK110223WAVEGUARD (TM) EEG CAPK070358MAXINSIGHT

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Related Devices (Code: OLX)

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.

K260563CN-Suite™FIND Surgical Sciences Inc. D/B/A FIND NeuroK252565PreOp v3Clouds of CareK250239NeuroMatchLVIS CorporationK241513SourcererBrain Electrophysiology Laboratory Company, LLCK233985TRIUX™ neo (NM27000N ); MEGreview (SW26241N-B)Megin OYK210199RICOH MEGRicoh Company, Ltd.

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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