510(k) K070710

ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM by Biosensors International-USA — Product Code DRS

K070710 is an FDA 510(k) premarket notification submitted by Biosensors International-USA for the device "ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM". The FDA issued a decision of Substantially Equivalent on April 19, 2007. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Biosensors International-USA has at least 1 other 510(k) clearance on record.