510(k) K103168

B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD) by Sorin Group Deutschland GmbH — Product Code DRY

K103168 is an FDA 510(k) premarket notification submitted by Sorin Group Deutschland GmbH for the device "B-CARE5 (B-CARE5 SENSOR MODULE, VENOUS SENSOR, HOLDER FOR MEASURING HEAD)". The FDA issued a decision of Substantially Equivalent on January 6, 2011. The device falls under product code DRY (Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4330. Sorin Group Deutschland GmbH has at least 10 other 510(k) clearances on record.