
Respironics, Inc.
Free shipping on orders over $99 · 30-day returns
OMNI 5 TOTAL O2 DELIVERY SYSTEM is an FDA 510(k)-cleared medical device (K091028) 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 July 22, 2009. Regulation: 8.