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The Hewlett Packard External Pediatic electrodes are indicated for use in external Pacing, Defibrillation and Monitoring applications as a non-sterile, disposable device pediatric patient use, only. The M3503A & M3504A electrodes provide the conductive interface between the defibrillator and/or the external transcutaneous (noninvasive) cardiac pacemaker and the pediatric patients skin. The electrode is intended for use on pediatric patients.

When a patient requires defibrillation, cardioversion or external pacing, these electrodes will be applied to the pediatic pationt and connected to the instrument. This device is intended for use on defibrillators whose output is classified as low power (360 Joule maximum.)

The M3503A & M3504A Pediatric electrodes are designed for, and to be used, with the the Hewlett Packard Codemaster Defibrillator.

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I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for "Hewlett Packard M3503A and M3504A Multifunction Pediatric Defib Electrodes" and mentions the indications for use, but it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

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