KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP

KARL STORZ PRESSURE CUFF FOR USE WITH THE KSEA HYDROMAT PUMP is an FDA 510(k)-cleared medical device (K951105) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Obstetrics/Gynecology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 19, 1995. Regulation: 8.