PULSE*SPRAY INFUSION SYSTEM

PULSE*SPRAY INFUSION SYSTEM is an FDA 510(k)-cleared medical device (K961763) manufactured by Angiodynamics, Div. E-Z-Em, 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 July 16, 1996. Regulation: 8.