SIMPLYGO PORTABLE OXYGEN CONCENTRATOR

SIMPLYGO PORTABLE OXYGEN CONCENTRATOR is an FDA 510(k)-cleared medical device (K111885) manufactured by Respironics, 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 November 3, 2011. Regulation: 8.