REGIONAL OXIMETER SYSTEM, MODEL 7600

REGIONAL OXIMETER SYSTEM, MODEL 7600 is an FDA 510(k)-cleared medical device (K090807) 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 June 29, 2009. Regulation: 8.