SIPHONX GRAVITATIONAL ANTISIPHON DEVICE

SIPHONX GRAVITATIONAL ANTISIPHON DEVICE is an FDA 510(k)-cleared medical device (K091328) manufactured by Sophysa SA. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 21, 2010. Regulation: 8.