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Medical Devices / Submissions and Approvals

Netech Grabs FDA Clearance for Defibrillator/ Pacemaker Analyzer

Sept. 11, 2019

Netech has received 510(k) clearance for its Delta 3300 device, a defibrillator and pacemaker analyzer that tests and validates the functions of semi-automated and automated defibrillators.

The portable product also measures external pacemakers.

The device tests for various metrics, including energy, peak discharge voltage and the simulation of ECG and arrhythmia waveforms, among others.

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