Bloom2 Programmable Electrophysiology Stimulator

Bloom2 Programmable Electrophysiology Stimulator is an FDA 510(k)-cleared medical device (K173439) manufactured by Fischer Medical. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 28, 2018. Regulation: 8.