MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING

MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSING is an FDA 510(k)-cleared medical device (K925510) manufactured by Spacelabs Medical, 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 October 26, 1994. Regulation: 8.