MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE

MEDFLATOR II(TM) DISPOSABLE INFLATION DEVICE is an FDA 510(k)-cleared medical device (K940896) manufactured by Medex, 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 August 10, 1994. Regulation: 8.