Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Rhythmlink International, LLC. It received FDA 510(k) clearance on 2020-05-27 under approval 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. It is manufactured by Rhythmlink International, LLC. The 510(k) number is K200984.

When was Guardian Needle Electrode approved by the FDA?

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

What company makes Guardian Needle Electrode?

Guardian Needle Electrode is manufactured by Rhythmlink International, LLC.

What is the FDA product code for Guardian Needle Electrode?

The FDA product code for Guardian Needle Electrode is GXZ.

Related Clinical Trials

NCT04910841 Feasibility of Using the "CGM GUARDIAN 2" Interstitial Fluid Glucose Measurement System in Intensive Care Medicine RECRUITING NCT07247825 Efficacy of Therapeutic Percutaneous Electrolysis vs Laser Therapy in Supraspinatus Tendinopathy. RECRUITING NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING

Other Devices by Rhythmlink International, LLC

K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode K191225EEG Electrode Template K190801PressOn Electrode Headset K203079MR Conditional Sticky Pad Electrode

Related Devices (Code: GXZ)

K161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd. K192603Spes Medica Subdermal Needle ElectrodesSpes Medica Srl K190801PressOn Electrode HeadsetRhythmlink International, LLC K232581Medical Disposable Sterile Needle ElectrodeSuzhou Haishen Medical Device Associates Co., Ltd. K231691Phantom XL Insulated DilatorsTeDan Surgical Innovations, Inc. K241045Disposable Subdermal Needle Electrode, CorkscrewTechnomed Europe

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.

↑