Spire Health Remote Patient Monitoring System

Spire Health Remote Patient Monitoring System is an FDA 510(k)-cleared medical device (K192952) manufactured by Spire, Inc. D/B/A Spire Health. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 4, 2020. Regulation: 8.