HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM

HP SONOS 500 AND SONOS 1000 ULTRA. IMAGING SYSTEM is an FDA 510(k)-cleared medical device (K896435) manufactured by Hewlett-Packard Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 6, 1990. Regulation: 8.