
Respironics New Jersey, Inc.
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LITETOUCH MASK is an FDA 510(k)-cleared medical device (K100285) manufactured by Respironics New Jersey, 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 28, 2010. Regulation: 8.