AD-TECH'S FORAMEN OVALE ELECTRODE

AD-TECH'S FORAMEN OVALE ELECTRODE is an FDA 510(k)-cleared medical device (K990788) manufactured by Ad-Tech Medical Instrument Corp. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 1, 1999. Regulation: 8.