Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option

Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option is an FDA 510(k)-cleared medical device (K191013) manufactured by Welch Allyn, 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 September 9, 2019. Regulation: 8.