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Fogg System Company has received US FDA 510(k) Class II regulatory clearance for its cable products. 

AURORA, COLORADO, 22 November, 2023 –  Fogg System Company, a leading supplier of medical cable products, announced that it has received U.S. Food and Drug Administration (FDA) Class II clearance for its Patient Monitoring Cable products.  Fogg System Patient Monitoring Cable products include Invasive Blood Pressure (IBP) Interface cables, IBP Adapter cables, and various analog cables used to transmit patient data.

Along with ISO 9001:2015 and ISO 13485:2016 quality certifications, this clearance marks a significant milestone in Fogg System Company being able to meet customer needs and increasing regulatory requirements.

Achieving FDA Class II clearance means that we will be able to concentrate our efforts toward compliance with the EU Medical Device Regulations and bringing our products to new markets.

Our partners, including Transducer and Monitor OEMs, both domestically and abroad, will be able to take advantage of our ability to provide solutions for their complex cable requirements while maintaining compliance with developing regulatory demands.

David Blair, President of Fogg System Company, said “We are pleased to have received 510(k) clearance for our Patient Monitoring Cable products.  With 510(k) clearance and plans for compliance with EU Medical Device Regulations, we are well-positioned to help our OEM partners with their cable requirements allowing them to focus on their core business.”

 About Fogg System

Fogg System Company is a leading manufacturer and supplier of Invasive Blood Pressure (IBP) Interface and Adapter cables, as well as Patient Simulators.

Please visit Fogg System Company at: https://www.foggsystem.com/ and follow us on LinkedIn at Fogg System Company.

 For additional information, contact:

Chris Richards, Sales
sales@foggsystem.com
303.344.1883

Fogg System Company, Inc.
15592 East Batavia Drive
Aurora, CO  80011
USA