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FDA 510(k)

Dome Electrode

K-Number: K190416 · 2019-04-04

ApplicantCoapt, LLC
Decision Date2019-04-04
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Dome Electrode is the device name listed in this FDA 510(k) record. The listed applicant is Coapt, LLC. It received FDA 510(k) clearance on 2019-04-04 under 510(k) number K190416. 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 Dome Electrode?

Dome Electrode is a medical device that received FDA 510(k) clearance on 2019-04-04. The listed applicant is Coapt, LLC. The 510(k) number is K190416.

When did Dome Electrode receive FDA 510(k) clearance?

Dome Electrode received FDA 510(k) clearance on 2019-04-04, under 510(k) number K190416.

Who is the listed applicant for Dome Electrode?

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

What is the FDA product code for Dome Electrode?

The FDA product code for Dome Electrode is GXY.

Other records listing Coapt, LLC 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.

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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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