Cleared Traditional

ICS Dizcovery (1091)

K242198 · Natus Medical Denmark Aps · Ear, Nose, Throat

Feb 2025

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K242198 is an FDA 510(k) clearance for the ICS Dizcovery (1091), a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Natus Medical Denmark Aps (Taastrup, DK). The FDA issued a Cleared decision on February 14, 2025, 203 days after receiving the submission on July 26, 2024. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K242198 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 2024
Decision Date	February 14, 2025
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF