FDA 510(k)

MR CONDITIONAL PRESSON ELECTRODE

K-Number: K130220 · 2013-07-22

Decision Date2013-07-22

Product CodeGXZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

MR CONDITIONAL PRESSON ELECTRODE is the device name listed in this FDA 510(k) record. The listed applicant is Rhythmlink International, LLC. It received FDA 510(k) clearance on 2013-07-22 under 510(k) number K130220. The device is classified under product code GXZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MR CONDITIONAL PRESSON ELECTRODE?

MR CONDITIONAL PRESSON ELECTRODE is a medical device that received FDA 510(k) clearance on 2013-07-22. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K130220.

When did MR CONDITIONAL PRESSON ELECTRODE receive FDA 510(k) clearance?

MR CONDITIONAL PRESSON ELECTRODE received FDA 510(k) clearance on 2013-07-22, under 510(k) number K130220.

Who is the listed applicant for MR CONDITIONAL PRESSON ELECTRODE?

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

What is the FDA product code for MR CONDITIONAL PRESSON ELECTRODE?

The FDA product code for MR CONDITIONAL PRESSON ELECTRODE is GXZ.

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Other records listing Rhythmlink International, LLC as applicant

K203079MR Conditional Sticky Pad Electrode K200984Guardian Needle Electrode K191225EEG Electrode Template K190801PressOn Electrode Headset K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode K130287MR CONDITIONAL CUP ELECTRODE, MR CONDITIONAL WEBB ELECTRODE

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Related Devices (Code: GXZ)

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K200984Guardian Needle ElectrodeRhythmlink International, LLC K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl K190801PressOn Electrode HeadsetRhythmlink International, LLC

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.