THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE

THE BUDDY SYSTEM W/OPTIONAL ECG ELECTRODE is an FDA 510(k)-cleared medical device (K871748) manufactured by The Buddy Systems, 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 June 9, 1987. Regulation: 8.