
Merits Health Products., Inc.
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MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS is an FDA 510(k)-cleared medical device (K011844) manufactured by Merits Health Products., 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 August 27, 2001. Regulation: 8.