Cleared Traditional

Grass? MR Conditional/CT Cup Electrodes

K242346 · Natus Manufacturing Limited · Neurology
Aug 2024
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K242346 is an FDA 510(k) clearance for the Grass? MR Conditional/CT Cup Electrodes, a Electrode, Cutaneous (Class II — Special Controls, product code GXY), submitted by Natus Manufacturing Limited (Gort, IE). The FDA issued a Cleared decision on August 29, 2024, 22 days after receiving the submission on August 7, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1320.

Submission Details

510(k) Number K242346 FDA.gov
FDA Decision Cleared SESE
Date Received August 07, 2024
Decision Date August 29, 2024
Days to Decision 22 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GXY — Electrode, Cutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1320

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