BioMonitor 2-AF, BioMonitor 2-S

BioMonitor 2-AF, BioMonitor 2-S is an FDA 510(k)-cleared medical device (K152995) 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 April 10, 2016. Regulation: 8.