Spaulding Clinical Receives FDA 510(k) Clearance for 12-Lead ECG Device
Wireless, hand-held electrocardiograph designed to streamline the collection and transmission of ECG data for
doctors and patients.
May 24, 2016 – West Bend, Wisconsin, USA – Spaulding Medical, LLC, a wholly owned subsidiary of Spaulding
Clinical Research, LLC and provider of cardiac safety solutions, today announced the FDA 510(k) Clearance for their newest 12-Lead ECG device: the Spaulding Electrocardiograph 2100iQ™.
The Spaulding 12-Lead ECG product line was originally launched in 2011 and is now in use in over 35 countries. The
Spaulding Electrocardiograph 2100iQ has been optimized to visualize collected real-time digital ECG data via
BluetoothⓇ using iOS™ 7+, Android™ 4.2+ and Windows™ 7+ devices. Data is wirelessly uploaded to the Spaulding
webECG™ management cloud for Cardiologist over-reads and is designed to integrate with electronic medical records
and clinical information management systems.
“The Spaulding Electrocardiograph 2100iQ is the tangible culmination of our mission to deliver high-quality data in
less time and at a reduced cost,” said Randol Spaulding, CEO of Spaulding Clinical. “With our FDA 510(k) Clearance
in place, we’ve reinforced our commitment to being an innovation leader in cardiac safety by providing patients,
partners and physicians with a mobile ECG solution our competitors cannot.”
About Spaulding Medical
Spaulding Medical, LLC is a wholly owned subsidiary of Spaulding Clinical Research, LLC. Spaulding Medical is where innovative engineering meets purposeful design, ushering in a new paradigm in cardiac safety. The Mission: to make hospital quality cardiac care affordable and accessible by leveraging 150 collective years of cardiac safety expertise into viable health solutions.