AMENDMENT LIFEPAK 100, NPN 045

AMENDMENT LIFEPAK 100, NPN 045 is an FDA 510(k)-cleared medical device (K851248) manufactured by Physio-Control 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 April 18, 1985. Regulation: 8.