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FDA 510(k)

Guardian Needle Electrode

K-Number: K200984 · 2020-05-27

ApplicantRhythmlink International, LLC
Decision Date2020-05-27
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Guardian Needle 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 2020-05-27 under 510(k) number K200984. 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 Guardian Needle Electrode?

Guardian Needle Electrode is a medical device that received FDA 510(k) clearance on 2020-05-27. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K200984.

When did Guardian Needle Electrode receive FDA 510(k) clearance?

Guardian Needle Electrode received FDA 510(k) clearance on 2020-05-27, under 510(k) number K200984.

Who is the listed applicant for Guardian Needle 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 Guardian Needle Electrode?

The FDA product code for Guardian Needle Electrode is GXZ.

Related Clinical Trials

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Other records listing Rhythmlink International, LLC as applicant

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Related Devices (Code: GXZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed EuropeK232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd.K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc.K192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK190801PressOn Electrode HeadsetRhythmlink International, LLCK161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.

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.

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