# K052944: Ambu White Sensor CFM, CFL

- Pathway: 510(k) (Traditional)
- Applicant: Ambu A/S
- Decided: Oct 25, 2006 after 370 days
- Product code: DRX (Electrode, Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Ambu® Disposable ECG Electrode: named in the summary without a submission number
- (no number) Red Dot 2560: named in the summary without a submission number

## Indications for use
Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram. The electrode is for single patient use only.

Source page: https://510kreport.com/device/K052944
Methodology: https://510kreport.com/methodology