510(k) K973067

DRTS REMOTE CONTROL DRAPE by Minrad, Inc. — Product Code JAA

K973067 is an FDA 510(k) premarket notification submitted by Minrad, Inc. for the device "DRTS REMOTE CONTROL DRAPE". The FDA issued a decision of Substantially Equivalent on October 16, 1997. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650. Minrad, Inc. has at least 10 other 510(k) clearances on record.