ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES

ENVITEC OXIPEN PULSE OXIMETER AND ACCESSORIES is an FDA 510(k)-cleared medical device (K070193) 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 May 1, 2007. Regulation: 8.