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FDA 510(k)

EEG Electrode Template

K-Number: K191225 · 2019-08-05

ApplicantRhythmlink International, LLC
Decision Date2019-08-05
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

EEG Electrode Template is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2019-08-05 under 510(k) number K191225. 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 EEG Electrode Template?

EEG Electrode Template is a medical device that received FDA 510(k) clearance on 2019-08-05. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K191225.

When did EEG Electrode Template receive FDA 510(k) clearance?

EEG Electrode Template received FDA 510(k) clearance on 2019-08-05, under 510(k) number K191225.

Who is the listed applicant for EEG Electrode Template?

The FDA 510(k) record lists Rhythmlink International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EEG Electrode Template?

The FDA product code for EEG Electrode Template is GXY.

Other records listing Rhythmlink International, LLC as applicant

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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

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

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