STONY BROOK MODEL EECP-MC1

STONY BROOK MODEL EECP-MC1 is an FDA 510(k)-cleared medical device (K882401) manufactured by Stony Brook Trading and Development Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 2, 1989. Regulation: 8.