510(k) K981747

BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX by Sunscope Intl., Inc. — Product Code DRS

K981747 is an FDA 510(k) premarket notification submitted by Sunscope Intl., Inc. for the device "BIOTRANS PRESSURE MONITORING KIT MODEL NUMBER BT XXXXXX". The FDA issued a decision of Substantially Equivalent on August 20, 1998. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Sunscope Intl., Inc. has at least 6 other 510(k) clearances on record.