Smart Check O2 (MA0236)

Smart Check O2 (MA0236) is an FDA 510(k)-cleared medical device (K250002) manufactured by Life Spark Medical, LLC. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 23, 2025. Regulation: 8.