SYSTEM, THERMAL REGULATING 74-DWJ

SYSTEM, THERMAL REGULATING 74-DWJ is an FDA 510(k)-cleared medical device (K960167) manufactured by Augustine Medical, 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 June 16, 1996. Regulation: 8.