CARE PAL, MODEL CPW-10X

CARE PAL, MODEL CPW-10X is an FDA 510(k)-cleared medical device (K091430) manufactured by Digio2 International Co., Ltd.. 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 20, 2009. Regulation: 8.