ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS

ENVITEC REUSABLE SOFTIP Y SPO2 SENSORS is an FDA 510(k)-cleared medical device (K060675) manufactured by Envitec-Wismar GmbH. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 16, 2006. Regulation: 8.