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

FDA 510(k)

PressOn Electrode Headset

K-Number: K190801 · 2019-07-10

ApplicantRhythmlink International, LLC
Decision Date2019-07-10
Product CodeGXZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PressOn Electrode Headset 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 2019-07-10 under 510(k) 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. The listed applicant is Rhythmlink International, LLC. The 510(k) number is K190801.

When did PressOn Electrode Headset receive FDA 510(k) clearance?

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

Who is the listed applicant for PressOn Electrode Headset?

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 PressOn Electrode Headset?

The FDA product code for PressOn Electrode Headset is GXZ.

Other records listing Rhythmlink International, LLC as applicant

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.

K203079MR Conditional Sticky Pad ElectrodeK200984Guardian Needle ElectrodeK191225EEG Electrode TemplateK172503MR Conditional Cup Electrode, MR Conditional Webb Electrode

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.K200984Guardian Needle ElectrodeRhythmlink International, LLCK192603Spes Medica Subdermal Needle ElectrodesSpes Medica SrlK161566DMS Disposable Subdermal Needle ElectrodesDaehan Medical Systems Co., Ltd.

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.

↑