TELEMETRY SYSTEM, BIOTEL 300

TELEMETRY SYSTEM, BIOTEL 300 is an FDA 510(k)-cleared medical device (K781836) manufactured by Spacelabs, 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 3, 1978. Regulation: 8.