P.H.D. - PERSONAL HEART DEVICE MODEL 5258

P.H.D. - PERSONAL HEART DEVICE MODEL 5258 is an FDA 510(k)-cleared medical device (K963904) manufactured by Heart Alert, 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 May 14, 1997. Regulation: 8.