LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103

LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 is an FDA 510(k)-cleared medical device (K033518) manufactured by Custom Plastic Products. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 9, 2004. Regulation: 8.