SOPHY SU8 PRESSURE ADJUSTABLE VALVE

SOPHY SU8 PRESSURE ADJUSTABLE VALVE is an FDA 510(k)-cleared medical device (K992465) 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 September 20, 2000. Regulation: 8.