NARCO TLECARE MINIATURE PRESSURE DOME

NARCO TLECARE MINIATURE PRESSURE DOME is an FDA 510(k)-cleared medical device (K810431) manufactured by Narco Bio-Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 1981. Regulation: 8.