MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D

MASIMO RESPONSABLE OXIMETRY SENSORS MODEL S2-25/25D; S2-20/20D is an FDA 510(k)-cleared medical device (K100617) manufactured by Masimo Corporation. 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 27, 2010. Regulation: 8.