
Transoma
Free shipping on orders over $99 · 30-day returns
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT is an FDA 510(k)-cleared medical device (K083828) manufactured by Transoma. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 10, 2009. Regulation: 8.