MODIFICATION TO INTEL HEALTH GUIDE PHS6000

MODIFICATION TO INTEL HEALTH GUIDE PHS6000 is an FDA 510(k)-cleared medical device (K101178) manufactured by Intel Corp.. 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 28, 2010. Regulation: 8.