MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS

MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS is an FDA 510(k)-cleared medical device (K014301) manufactured by Merits Health Products Co., Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2002. Regulation: 8.