510(k) K112203

COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST by Mirador Biomedical, Inc. — Product Code DRS

K112203 is an FDA 510(k) premarket notification submitted by Mirador Biomedical, Inc. for the device "COMPASS GLOBAL PRESSURE, COMPASS THORACENTESIS, PARACENTESIS, COMPARTMENT PRESSURE, EPIDURAL ASSIST, ARTERIAL ASSIST". The FDA issued a decision of Substantially Equivalent on December 14, 2011. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Mirador Biomedical, Inc. has at least 3 other 510(k) clearances on record.