Fluke Biomedical Submits FDA 510(k) for Impulse 7010 Defibrillator Selectable Load Accessory
November 14, 2008 - Fluke Biomedical said today it made a FDA 510(k) submission for the Impulse 7010 Defibrillator Selectable Load Accessory to test defibrillators beyond 175 ohms.
In conjunction with the already-available new Impulse 7000DP Defibrillator/External Pacer Analyzer, the expected release of the Impulse 7010 supports defibrillator performance through the spectrum of patient impedances.
The company said the easy-to-use tool provides the capability to test defibrillators under a variety of patient impedance conditions, from 25 ohms to 200 ohms. The Impulse 7010 allows manufacturers to comply with IEC60601-2-4 and AAMI DF80 standards for impedance testing, the company said. This allows users to follow any manufacturers’ product-inspection procedures to ensure proper defibrillator functionality on patients with different impedances.
For more information: www.flukebiomedical.com
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