Cleared Traditional

PressOn Electrode Headset

K190801 · Rhythmlink International, LLC · Neurology
Jul 2019
Decision
103d
Days
Class 2
Risk

About This 510(k) Submission

K190801 is an FDA 510(k) clearance for the PressOn Electrode Headset, a Electrode, Needle (Class II — Special Controls, product code GXZ), submitted by Rhythmlink International, LLC (Columbia, US). The FDA issued a Cleared decision on July 10, 2019, 103 days after receiving the submission on March 29, 2019. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1350.

Submission Details

510(k) Number K190801 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2019
Decision Date July 10, 2019
Days to Decision 103 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXZ — Electrode, Needle
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1350

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