BOOKER BOX, MODEL PAD 5010

BOOKER BOX, MODEL PAD 5010 is an FDA 510(k)-cleared medical device (K993205) manufactured by Tz 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 19, 2000. Regulation: 8.