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FDA 510(k)

MR Conditional Sticky Pad Electrode

K-Number: K203079 · 2021-02-09

Decision Date2021-02-09
Product CodeGXY
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MR Conditional Sticky Pad Electrode is a medical device manufactured by Rhythmlink International, LLC. It received FDA 510(k) clearance on 2021-02-09 under approval number K203079. 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 Sticky Pad Electrode?

MR Conditional Sticky Pad Electrode is a medical device that received FDA 510(k) clearance on 2021-02-09. It is manufactured by Rhythmlink International, LLC. The 510(k) number is K203079.

When was MR Conditional Sticky Pad Electrode approved by the FDA?

MR Conditional Sticky Pad Electrode received FDA 510(k) clearance on 2021-02-09, under approval number K203079.

What company makes MR Conditional Sticky Pad Electrode?

MR Conditional Sticky Pad Electrode is manufactured by Rhythmlink International, LLC.

What is the FDA product code for MR Conditional Sticky Pad Electrode?

The FDA product code for MR Conditional Sticky Pad Electrode is GXY.

Other Devices by Rhythmlink International, LLC

Related Devices (Code: GXY)

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.