Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)

Informed Vital Core Application (IVC App) (v2.0.0.2.0.0) is an FDA 510(k)-cleared medical device (K250078) manufactured by Mindset Medical, 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 May 29, 2025. Regulation: 8.