FDA 510(k)

PressOn Electrode Headset

K-Number: K190801 · 2019-07-10

Decision Date2019-07-10

Product CodeGXZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PressOn Electrode Headset is a medical device manufactured by Rhythmlink International, LLC. It received FDA 510(k) clearance on 2019-07-10 under approval number K190801. 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 PressOn Electrode Headset?

PressOn Electrode Headset is a medical device that received FDA 510(k) clearance on 2019-07-10. It is manufactured by Rhythmlink International, LLC. The 510(k) number is K190801.

When was PressOn Electrode Headset approved by the FDA?

PressOn Electrode Headset received FDA 510(k) clearance on 2019-07-10, under approval number K190801.

What company makes PressOn Electrode Headset?

PressOn Electrode Headset is manufactured by Rhythmlink International, LLC.

What is the FDA product code for PressOn Electrode Headset?

The FDA product code for PressOn Electrode Headset is GXZ.

Other Devices by Rhythmlink International, LLC

K172503MR Conditional Cup Electrode, MR Conditional Webb Electrode K191225EEG Electrode Template K200984Guardian Needle Electrode 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 K200984Guardian Needle ElectrodeRhythmlink 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.