← Product Code [GXY](/productcode/GXY) · 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) (K260578)

_Ambu A/S · GXY · Jul 14, 2026 · Neurology · SESE_

**Canonical URL:** https://fda.innolitics.com/device/K260578

## Device Facts

- **Applicant:** Ambu A/S
- **Product Code:** [GXY](/productcode/GXY.md)
- **Decision Date:** Jul 14, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 882.1320
- **Device Class:** Class 2
- **Review Panel:** Neurology

## Regulatory Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

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**Source:** [https://fda.innolitics.com/device/K260578](https://fda.innolitics.com/device/K260578)

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