News | January 15, 2009

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

Related Content

The Zoll LifeVest wearable defibrillator was the subject of the VEST Trial

The Zoll LifeVest wearable defibrillator system was evaluated in the late-breaking VEST Trial presented at ACC 2018 earlier this year.

Feature | Defibrillator Monitors | July 10, 2018 | Michael J. Mirro, M.D.
Following the...
Rice University Students Improve AED Operation With Needle Pad

The automated external defibrillator add-on developed by Rice University students is a pad of needles that break through the skin's natural impedance barrier to deliver an electric shock to the heart of a patient in cardiac arrest. (Credit: Jeff Fitlow/Rice University)

News | Defibrillator Monitors | April 16, 2018
The skin presents a formidable barrier to life-saving defibrillators, but a team of students from Rice University...
Zoll Canada Equipping Province of Québec Paramedic Services with X Series Monitor/Defibrillators
News | Defibrillator Monitors | October 16, 2017
October 16, 2017 — Zoll Canada, a subsidiary of Zoll Medical Corp., announced it has won the tender to equip all ambu
Physio-Control Launches HeartSine samaritan PAD 360P Automated External Defibrillator in United States
Technology | Defibrillator Monitors | April 24, 2017
Physio-Control announced April 19 that the company’s HeartSine samaritan PAD 360P (SAM 360P) fully automatic external...
AEDs, automated external defibrillators, requirements, U.S. schools, JACC study
News | Defibrillator Monitors | March 30, 2017
Automated external defibrillators (AEDs) are associated with increased survival of sudden cardiac arrest when installed...
Philips, FDA, class I recall, HeartStart MRx Monitor/Defibrillator
News | Defibrillator Monitors | March 28, 2017
Philips and the U.S. Food and Drug Administration (FDA) announced the company has initiated a recall of its HeartStart...
Zoll, Hospital Wearable Defibrillator, HWD, FDA premarket approval
Technology | Defibrillator Monitors | March 10, 2017
Zoll Medical Corp. announced that the company’s Hospital Wearable Defibrillator (HWD) has been granted premarket...
Zoll LifeVest wearable defibrillator, WEARIT-II Registry results, CardioStim EuroPace 2016
News | Defibrillator Monitors | June 21, 2016
Zoll Medical Corp. announced that patients experience a high one-year survival rate following use of the LifeVest...
defibrillator-monitors, defibrillator monitor

Physio-Control's LifePAK15

Feature | Defibrillator Monitors | February 03, 2014 | Dave Fornell
For U.S. hospitals and emergency medical services (EMS) looking to upgrade their aging defibrillator-monitors, new...
Overlay Init