MR Conditional Cup Electrodes
K-Number: K254183 · 2026-05-07
ApplicantTechnomed Europe
Decision Date2026-05-07
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
MR Conditional Cup Electrodes is a medical device manufactured by Technomed Europe. It received FDA 510(k) clearance on 2026-05-07 under approval number K254183. 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 MR Conditional Cup Electrodes?
MR Conditional Cup Electrodes is a medical device that received FDA 510(k) clearance on 2026-05-07. It is manufactured by Technomed Europe. The 510(k) number is K254183.
When was MR Conditional Cup Electrodes approved by the FDA?
MR Conditional Cup Electrodes received FDA 510(k) clearance on 2026-05-07, under approval number K254183.
What company makes MR Conditional Cup Electrodes?
MR Conditional Cup Electrodes is manufactured by Technomed Europe.
What is the FDA product code for MR Conditional Cup Electrodes?
The FDA product code for MR Conditional Cup Electrodes is GXY.
Related Devices (Code: GXY)
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.