News | November 13, 2008

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

Related Content

The FDA is concerned about cybersecurity of ICDs and cyber security of other medical devices.
Feature | Cybersecurity| August 16, 2017 | Dave Fornell
There is growing concern among patients and regulators that medical devices, especially implantable electrophysiology
Three New Atrial Fibrillation Studies to Feature HeartLight Endoscopic Ablation System
News | Ablation Systems| August 07, 2017
CardioFocus Inc. announced that its HeartLight Endoscopic Ablation System is being featured in three new major clinical...
Merge Hemo cath lab hemodynamics monitoring system.

Hemodynamic data shown on screens from the Merge Hemo recording system. It is among the newer generation hemodynamic systems for cath labs that are more user friendly and have technologies to speed workflow.

Feature | Hemodynamic Monitoring Systems| August 03, 2017 | Dave Fornell
The current generation of...
Left Atrial Pressure Monitor from Vectorious Medical Technologies Offers New Hope for Heart Failure Patients

On of the top stories in July was the introduction of a left atrial pressure monitor from Vectorious Medical Technologies to prevent heart failure patient hospitalizations or readmissions. Read the article"Left Atrial Pressure Monitor Offers New Hope for Heart Failure Patients."

Feature | August 01, 2017 | Dave Fornell
Aug.
Ohio State Researchers Prove Human Heart's 'Battery' Has Multiple Backups
News | EP Lab| July 27, 2017
July 27, 2017 — There is good news when it comes to the heart’s sinoatrial node (SAN), the body’s natural...
Medtronic Announces First Enrollments in STOP AF First Clinical Trial
News | Ablation Systems| July 24, 2017
Medtronic plc recently announced first enrollments in the STOP AF First clinical trial. The trial will evaluate the...
Biotronik Launches DX Technology for U.S. Heart Failure Patients
News | Cardiac Resynchronization Therapy Devices (CRT)| July 21, 2017
Biotronik announced U.S. Food and Drug Administration (FDA) approval and availability of the Intica DX and Intica...
Cardiologs ECG Analysis Platform Receives FDA Clearance
Technology | ECG Monitoring Services| July 13, 2017
Cardiologs Technologies SAS announced that it has received U.S. Food and Drug Administration (FDA) clearance of its...
Overlay Init