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FOR IMMEDIATE RELEASE
1/14/2009
Fluke Biomedical announces FDA 510(k) approval of new Impulse 7010 Defibrillator Selectable Load Accessory

CLEVELAND, OHIO – Fluke Biomedical is pleased to announce the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the only product available today to test defibrillators beyond 175 ohms, the Impulse 7010 Defibrillator Selectable Load Accessory. 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.

This unique, robust and extremely 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," notes Hongbo Chen, Product Manager for Fluke Biomedical, "and also allows technicians to follow any manufacturers' product-inspection procedures to ensure proper defibrillator functionality on patients with different impedances."

About Fluke Biomedical
Fluke Biomedical, a division of Fluke Corporation, is a manufacturer of quality biomedical test and simulation products and a provider of the latest medical imaging and oncology quality-assurance solutions for regulatory compliance.

About Fluke Corporation
Fluke Corporation is the world leader in compact, professional electronic test tools. Fluke customers are technicians, engineers, electricians and metrologists who install, troubleshoot and manage industrial electrical, biomedical and electronic equipment and calibration processes for quality control.

 

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