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Ambu Paediatic Multi-Function Defibrillation Electrodes are used for defibrillation, pacing, monitoring ECG applications and synchronized cardioversion.

The Paediatic Multi-Function Defibrillation Electrodes may be used with Class III type of external defibrillators (automated external defibrillators) or class II type of transcutaneous external pacemakers (pulse amplitude not to exceed 200mA in pulse duration not to exceed 200 m sec.

The electrode can be used with mono- and biphasic defibriliators.

The electrode is intended for use on pediatric patients whose weight is less than 10kg (22lbs).

Disposable electrode, for single use, only,

The electrode is intended for use on defibrillators who's output is maximum 100 Joule.

Individual catalogue numbers are labeled for specific use primarily based on the interface connector and cable system which defines the host external device.

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This document is a 510(k) clearance letter from the FDA for a medical device: "Ambu Pediatric Multi-Function Defibrillation Electrodes." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It discusses regulatory classifications, general controls, and responsibilities under the Federal Food, Drug, and Cosmetic Act.

The "Indications for Use" section (page 2) describes what the electrodes are designed for (defibrillation, pacing, monitoring ECG, synchronized cardioversion) and specific patient/device parameters (pediatric patients

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