Ultrasound acoustic measurement and testing firm Acertara Acoustic Laboratories recently reached the milestone of 900 successful submissions for 510(k) clearance.
A 510(k) application is submitted to the U.S. 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. Acertara performs 510(k) submissions and regulatory consulting for clients with products ranging from new ultrasound scanners to replacement arrays and implantable devices.
