RESPIRATORY SENSOR (MODEL 409 W/NASOPH.)

RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) is an FDA 510(k)-cleared medical device (K811265) manufactured by Impact Instrumentation, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 1, 1981. Regulation: 8.