Acertara Acoustic Laboriatores, an independent medical ultrasound acoustic measurement, testing, and calibration laboratory based in Longmont, Colo, announced that it has reached its 900th submission for 510(k) clearance. In addition to ultrasound probe repair and testing equipment, the company provides engineering, regulatory, and testing services for original equipment manufacturers undergoing the 510(k) submission process.
“We appreciate our customers around the globe who have entrusted their Acoustic Power Testing and 510(k) submissions to the team at Acertara. This milestone further exemplifies Acertara’s established expertise in turn-key FDA 510(k) submissions and regulatory consulting services,” said G. Wayne Moore, President and CEO of Acertara, in an announcement. “As the only independent ISO 17025-accredited laboratory in the world, our customers enjoy competent, impartial, and, therefore, credible test results that can be utilized with their 510(k).”
For more information, visit the Acertara Acoustic Laboratories website.