BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX is an FDA 510(k)-cleared medical device (K981747) 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 August 19, 1998. Regulation: 8.