K260578

Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)

510(k) number: K260578
Device name: Ambu® NeurolineTM Cup MRI/CT (Models 72704/21US, 72704/23US, 72704/25US, 72704/27US) Ambu® NeurolineTM Cup MRI/CT-set (Models 72704/21-1010US, 72704/21-1010US, 72704/23-1010US, 72704/25-1010US, 72704/27-1010US) Ambu® NeurolineTM Cup MRI/CT-mini set (Models 72704/21-0301US, 72704/23-0301US, 72704/25-0301US, 72704/27-0301US)
Applicant: Ambu A/S DK
Product code: GXY — Electrode, Cutaneous
Decision date: 2026-07-14
Date received: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Neurology

PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K260578.pdf

Official FDA record: K260578

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.