Makani Science™ Respiration Monitoring System

Makani Science™ Respiration Monitoring System is an FDA 510(k)-cleared medical device (K233953) manufactured by Makani Science, 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 March 27, 2025. Regulation: 8.