Acertara Acoustic Laboratories, an independent ISO/IEC 17025:2005 accredited medical ultrasound acoustic measurement, testing, and calibration laboratory, and ISO 13485:2003 certified probe repair and new product development facility, announces that it has recently reached 900 successful submissions for 510(k) pre-market notification.
A 510(k) is submitted to the Food and Drug Administration (FDA) to demonstrate that a medical device is safe and effective for clinical use based on an equivalent device already on the market.
“We appreciate our customers around the globe who have entrusted their Acoustic Power Testing and 510(k) submissions to the team at Acertara,” G. Wayne Moore, President and CEO of Acertara, said regarding the milestone. “From new ultrasound systems to replacement arrays to implantable devices our team has seen it all. This milestone further exemplifies Acertara’s established expertise in turn-key FDA 510(k) submissions and regulatory consulting services. 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).”
