BIOMONITOR IIIm, BIOMONITOR III

BIOMONITOR IIIm, BIOMONITOR III is an FDA 510(k)-cleared medical device (K221856) manufactured by Biotronik, 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 July 26, 2022. Regulation: 8.