Fluke Biomedical Gains FDA 510(k) Clearance for Impulse 7010 Defibrillator Selectable Load Accessory
January 16, 2009 – The FDA granted Fluke Biomedical U.S. Food and Drug 510(k) clearance for the Impulse 7010 Defibrillator Selectable Load Accessory to test defibrillators beyond 175 ohms.
Used in conjunction with the recently introduced Impulse 7000DP Defibrillator/External Pacer Analyzer, the Impulse 7010 supports defibrillator performance through the spectrum of patient impedances, the company said.
This robust and easy-to-use tool provides the capability to test defibrillators under a variety of patient impedance conditions, from 25 ohms to 200 ohms. The company said the Impulse 7010 allows manufacturers to comply with IEC60601-2-4 and AAMI DF80 standards for impedance testing and allows technicians 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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