ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN

ENVITEC REUSABLE SPO2 SENSORS TYPE NIHON-KOHDEN is an FDA 510(k)-cleared medical device (K102270) 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 February 21, 2011. Regulation: 8.