PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T

PHILIPS SPO2 REUSABLE SENSOR, MODELS M1196A AND M1196T is an FDA 510(k)-cleared medical device (K062605) manufactured by Philips Medical Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 8, 2006. Regulation: 8.