BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX

BIOTRANS REUSABLE SENSOR BASE MODEL NUMBER BT XXXXXX is an FDA 510(k)-cleared medical device (K981745) manufactured by Sunscope Intl., 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 July 16, 1998. Regulation: 8.