Regulacje i polityka gospodarcza · 29/11/1996

Advanced Technology Laboratories; Premarket Approval of UltramarkRegister 9 High DefinitionSUPTM Imaging (HDISUPTM) Ultrasound System With L10-5 Scanhead

The Food and Drug Administration (FDA) is announcing its approval of the application by Advanced Technology Laboratories, Bothell, WA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of Ultramark 9 HDI TM Ultrasound System with L10-5 Scanhead. After reviewing the recommendation of the Radiological Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter on April 11, 1996, of the approval of the application.