CLASS II DEVICE FOR I.C.P. MONITORING

CLASS II DEVICE FOR I.C.P. MONITORING is an FDA 510(k)-cleared medical device (K822636) manufactured by Philadelphia Medical Specialties. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 13, 1982. Regulation: 8.