510(k) K833095

TRANSDUCER DOME SD105 by Sorensen Research — Product Code DRS

K833095 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "TRANSDUCER DOME SD105". The FDA issued a decision of Substantially Equivalent on November 3, 1983. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Sorensen Research has at least 10 other 510(k) clearances on record.