SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER

SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER is an FDA 510(k)-cleared medical device (K990927) manufactured by Perry Baromedical Corp.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 11, 1999. Regulation: 8.