SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES

SIEMENS SONOLINE SI-450, OB/GYN,ENT,DENTAL DEVICES is an FDA 510(k)-cleared medical device (K904017) manufactured by Siemens Ultrasound, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 20, 1991. Regulation: 8.