510(k) K983372

BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP by Sunscope Intl., Inc. — Product Code DRS

K983372 is an FDA 510(k) premarket notification submitted by Sunscope Intl., Inc. for the device "BIOPORT CLOSED BLOOD SAMPLING SYSTEM, MODEL BT XXXXXX- BP". The FDA issued a decision of Substantially Equivalent on February 5, 1999. 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.