A-V IMPULSE SYSTEM MODEL 6060

A-V IMPULSE SYSTEM MODEL 6060 is an FDA 510(k)-cleared medical device (K951683) manufactured by Novamedix , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 25, 1995. Regulation: 8.