Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense

Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is an FDA 510(k)-cleared medical device (K223246) manufactured by Baxter Healthcare Corproration. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 17, 2022. Regulation: 8.