
Medical Data Electronics
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MODIFICATION TO:ESCORT VISION CENTRAL STATION TELEMETRY SYSTEM, MODEL 20500 is an FDA 510(k)-cleared medical device (K012336) manufactured by Medical Data Electronics. 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 2, 2001. Regulation: 8.