No Carolina / NY / Florida
Ph: 561.316.3330

No Carolina / NY / Florida       

CerroZone Receives FDA 510(k) Class II Clearance

What To Know

  • “This is the first technology to truly harness the disinfecting power of ozone in a way that is safe for consumers and the environment,” said Michael Duggan, President of St.
  • To show similar effectiveness on a different strain reinforces that CerroZone is positioned to aid the public in the fight against emerging and future variants.

CerroZone ™ LLC’s new mobile air purification device has earned 510(k) Class II clearance from the U.S. Food and Drug Administration as a recirculating air cleaner for eliminating airborne viruses and bacteria. The FDA approval was contingent on extensive testing at accredited independent third-party facilities.

The CerroZone mobile unit is designed to purify air in buildings such as schools, retail environments, offices, and other indoor spaces. CerroZone’s indoor system achieved a 99.998 percent reduction of live COVID-19 Delta Variant in a single pass of approximately 1.2 seconds, according to independent testing at MRI Global in Kansas City.

Unlike other solutions, the CerroZone product features patented ozone technology. “This is the first technology to truly harness the disinfecting power of ozone in a way that is safe for consumers and the environment,” said Michael Duggan, President of St. Louis, Mo.-based CerroZone. “It will fundamentally change the industry standard for air purification.”

CerroZone previously announced it had achieved Intertek’s Zero Ozone Certification. Intertek considers emissions of .005 ppm or less to be negligible per UL 2998, the North American industry standard for ozone testing. The CerroZone unit recorded at only .001 ppm.

Among its benefits to the market, the CerroZone™ platform only requires annual preventive maintenance, unlike filtration-based systems that need quarterly replacement of filters and other components.

“Today’s news further validates the exceptional quality of our system,” said Marlon Robinson, Director of Operations for CerroZone. “We knew the effectiveness of the CerroZone unit based on our prior testing, including on live COVID-19. To show similar effectiveness on a different strain reinforces that CerroZone is positioned to aid the public in the fight against emerging and future variants.”

Robinson added, “We are now ready to commercialize this amazing technology. We have been methodical in our approach, with successful field trials consistently demonstrating our product’s performance. We look forward to providing the market with an effective, proven solution including an attractive preventive maintenance schedule.”

The patented CerroZone system was developed in conjunction with Micron Pure™, a Hecto Group™ company.

CerroZone is part of the Marmon Plumbing & Refrigeration group of Chicago-based Marmon Holdings, Inc. Marmon Holdings, a Berkshire Hathaway company, is a global industrial organization comprising 11 diverse business groups and more than 100 autonomous manufacturing and service businesses.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More

Advertise wiith Medical Device News Magazine

By using this website you agree to accept Medical Device News Magazine Privacy Policy