
Omron Healthcare, Inc.
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OMRON MICRO-AIR VIBRATING MESH NEBULIZER, MODEL NE-U22 is an FDA 510(k)-cleared medical device (K062263) manufactured by Omron Healthcare, 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 February 22, 2007. Regulation: 8.