EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP)

EXTERNAL HELIUM SUPPLY (ACCESSORY FOR IABP) is an FDA 510(k)-cleared medical device (K950687) manufactured by Belmont Instrument Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on May 23, 1995. Regulation: 8.