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FDA 510(k)

E-EEGX, N-EEGX

K-Number: K191322 · 2020-01-22

ApplicantGE Healthcare Finland Oy
Decision Date2020-01-22
Product CodeOLT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

E-EEGX, N-EEGX is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare Finland Oy. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K191322. The device is classified under product code OLT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the E-EEGX, N-EEGX?

E-EEGX, N-EEGX is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is GE Healthcare Finland Oy. The 510(k) number is K191322.

When did E-EEGX, N-EEGX receive FDA 510(k) clearance?

E-EEGX, N-EEGX received FDA 510(k) clearance on 2020-01-22, under 510(k) number K191322.

Who is the listed applicant for E-EEGX, N-EEGX?

The FDA 510(k) record lists GE Healthcare Finland Oy as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for E-EEGX, N-EEGX?

The FDA product code for E-EEGX, N-EEGX is OLT.

Other records listing GE Healthcare Finland Oy as applicant

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Related Devices (Code: OLT)

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.

K253767UB ERP SystemUniversal BrainK251881HippoMind (v1.0)HippoclinicK251366EEG-1260A Neurofax System (EEG-1260A); JE-940A EEG Amplifier Unit (JE-940A); LS-940A Photic Stimulator (LS-940A)Nihon Kohden CorporationK240593VEEGix EEG SystemNeuroServo, Inc.K220254Neuron-Spectrum-AM with Neuron-Spectrum.NET SoftwareNeurosoft , Ltd.K213299Wireless EEG SystemPascall Systems, Inc.

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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