NeuroSwift Pro— 510(k) K223047

Substantially Equivalent

Neurobit Technologies Co., Ltd.

FDA 510(k) clearance K223047 for NeuroSwift Pro, Substantially Equivalent on 2023-06-29. Applicant: Neurobit Technologies Co., Ltd.. Device class: 2.

Clearance details

Applicant: Neurobit Technologies Co., Ltd.
Product code: Code GWN
Device class: Class 2
Regulation: 21 CFR 882.1460
Advisory panel: Neurology
Date received: 2022-09-29
Decision date: 2023-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.