
Respironics Respiratory Drug Delivery (Uk) , Ltd.
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I-NEB AAD SYSTEM WITH TIM; I-NEB INSIGHT AAD SYSTEM is an FDA 510(k)-cleared medical device (K102454) manufactured by Respironics Respiratory Drug Delivery (Uk) , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 24, 2011. Regulation: 8.