PCI MODEL RS100 TELEMETRY MONITOR

PCI MODEL RS100 TELEMETRY MONITOR is an FDA 510(k)-cleared medical device (K874387) manufactured by Accucore, 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 December 17, 1987. Regulation: 8.