MODIFICATION TO M2376A DEVICELINK SYSTEM

MODIFICATION TO M2376A DEVICELINK SYSTEM is an FDA 510(k)-cleared medical device (K013470) manufactured by Philips Medical Systems, 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 November 13, 2001. Regulation: 8.