Ambu Blue Sensor Neo and Neo X
FDA 510(k)Class II (US FDA 510(k))
by Ambu A/S
Identifiers
- 510(k) Number
- K053550 FDA 510(k)
- FDA Product Code
- DRX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2360 FDA 510(k)
- Regulation Number
- 870.2360 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Ambu Blue Sensor Neo and Neo X are self-adhesive ECG electrodes designed for neonatal and paediatric ECG monitoring, classified under the nomenclature for disposable electrocardiographic electrodes. These electrodes facilitate the detection and transmission of electrical signals from the skin to external monitoring devices, enabling continuous cardiac assessment in infants and young children.
Supplied as disposable, single-use devices, the Neo and Neo X feature a multi-layer construction with a pre-attached lead wire and connector, hydrogel adhesive, and a protective top film. They are intended for use in clinical settings such as neonatal intensive care units (NICUs) and paediatric wards, adhering to standard ECG monitoring protocols. No specific regulatory status beyond the FDA 510(k) clearance is stated, and their use is governed by physician orders as per standard medical practice.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Ambu® BlueSensor ECG Electrodes, AMBU BLUE SENSOR NEO, AMBU BLUE SENSOR NEO X (K100129) — FDA 510(k ..., AMBU BLUE SENSOR NEO AND NEO X - fda.innolitics.com, Ambu® Blue Sensor NEO X User Guide
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K053550 | Class II | Active |
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Manufacturer
- Manufacturer
- Ambu A/S
Sources (1)
- FDA 510(k) K053550 24 fields · synced Sep 19, 2026