REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES is an FDA 510(k)-cleared medical device (K092101) manufactured by Nonin Medical, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 20, 2009. Regulation: 8.