CSS-60 DIGITAL HEART RATE METER

CSS-60 DIGITAL HEART RATE METER is an FDA 510(k)-cleared medical device (K780702) manufactured by Burdick 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 May 18, 1978. Regulation: 8.