Cleared Special

Natus Ultrapro S100 (982A0594)

K243495 · Natus Neurology Incorporated · Neurology
Dec 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243495 is an FDA 510(k) clearance for the Natus Ultrapro S100 (982A0594), a Stimulator, Electrical, Evoked Response (Class II — Special Controls, product code GWF), submitted by Natus Neurology Incorporated (Middleton, US). The FDA issued a Cleared decision on December 12, 2024, 30 days after receiving the submission on November 12, 2024. This device falls under the Neurology review panel. Regulated under 21 CFR 882.1870.

Submission Details

510(k) Number K243495 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 2024
Decision Date December 12, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF

Device Classification

Product Code GWF — Stimulator, Electrical, Evoked Response
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.1870

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