TMS COMFORT SERIES NASAL CPAP MASK

TMS COMFORT SERIES NASAL CPAP MASK is an FDA 510(k)-cleared medical device (K964092) manufactured by Tiara Medical Systems, 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 30, 1997. Regulation: 8.