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FDA 510(k)

MR Conditional Cup Electrode, MR Conditional Webb Electrode

K-Number: K172503 · 2017-12-01

ApplicantRhythmlink International, LLC
Decision Date2017-12-01
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MR Conditional Cup Electrode, MR Conditional Webb Electrode is a medical device manufactured by Rhythmlink International, LLC. It received FDA 510(k) clearance on 2017-12-01 under approval number K172503. 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 Electrode, MR Conditional Webb Electrode?

MR Conditional Cup Electrode, MR Conditional Webb Electrode is a medical device that received FDA 510(k) clearance on 2017-12-01. It is manufactured by Rhythmlink International, LLC. The 510(k) number is K172503.

When was MR Conditional Cup Electrode, MR Conditional Webb Electrode approved by the FDA?

MR Conditional Cup Electrode, MR Conditional Webb Electrode received FDA 510(k) clearance on 2017-12-01, under approval number K172503.

What company makes MR Conditional Cup Electrode, MR Conditional Webb Electrode?

MR Conditional Cup Electrode, MR Conditional Webb Electrode is manufactured by Rhythmlink International, LLC.

What is the FDA product code for MR Conditional Cup Electrode, MR Conditional Webb Electrode?

The FDA product code for MR Conditional Cup Electrode, MR Conditional Webb 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.

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