Cleared Traditional

NeuroSwift Pro

K223047 · Neurobit Technologies Co., Ltd. · Ear, Nose, Throat

Jun 2023

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K223047 is an FDA 510(k) clearance for the NeuroSwift Pro, a Nystagmograph (Class II — Special Controls, product code GWN), submitted by Neurobit Technologies Co., Ltd. (Taipei, TW). The FDA issued a Cleared decision on June 29, 2023, 273 days after receiving the submission on September 29, 2022. This device falls under the Ear, Nose, Throat review panel. Regulated under 21 CFR 882.1460.

Submission Details

510(k) Number	K223047 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2022
Decision Date	June 29, 2023
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Ear, Nose, Throat (EN)
Summary	Summary PDF