KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION

KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION is an FDA 510(k)-cleared medical device (K083598) manufactured by KARL STORZ Endoscopy-America, Inc.. This device is classified under the Gastroenterology, Urology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 28, 2009. Regulation: 8.