IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING

IMAGYN MEDICAL INFLATION DEVICE WITH NON-INVASIVE PRESSURE TUBING is an FDA 510(k)-cleared medical device (K940425) manufactured by Imagyn 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 July 31, 1994. Regulation: 8.