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 a medical device manufactured by Coapt, LLC. It received FDA 510(k) clearance on 2019-04-04 under approval 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. It is manufactured by Coapt, LLC. The 510(k) number is K190416.
When was Dome Electrode approved by the FDA?
Dome Electrode received FDA 510(k) clearance on 2019-04-04, under approval number K190416.
What company makes Dome Electrode?
Dome Electrode is manufactured by Coapt, LLC.
What is the FDA product code for Dome Electrode?
The FDA product code for Dome Electrode is GXY.
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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.