LifeWindow LW8 Lite

LifeWindow LW8 Lite is an FDA 510(k)-cleared medical device (K183687) manufactured by Digicare Biomedical Technology, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2019. Regulation: 8.