Biomonitor III, Biomonitor IIIm

Biomonitor III, Biomonitor IIIm is an FDA 510(k)-cleared medical device (K201865) 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 December 7, 2020. Regulation: 8.