510(k) K875357

BIOPSY FIXATION UNIT-TYPE UA 0997 by Bruel & Kjaer Industri A/S — Product Code IYO

K875357 is an FDA 510(k) premarket notification submitted by Bruel & Kjaer Industri A/S for the device "BIOPSY FIXATION UNIT-TYPE UA 0997". The FDA issued a decision of Substantially Equivalent on July 1, 1988. The device falls under product code IYO (System, Imaging, Pulsed Echo, Ultrasonic), a Class II device regulated under 21 CFR 892.1560. Bruel & Kjaer Industri A/S has at least 3 other 510(k) clearances on record.