510(k) K870653

ULTRASOUND LINEAR/SECTOR SCANNER 1100 by Pie Data Medical BV — Product Code KNG

K870653 is an FDA 510(k) premarket notification submitted by Pie Data Medical BV for the device "ULTRASOUND LINEAR/SECTOR SCANNER 1100". The FDA issued a decision of Substantially Equivalent on February 2, 1988. The device falls under product code KNG (Monitor, Ultrasonic, Fetal), a Class II device regulated under 21 CFR 884.2660. Pie Data Medical BV has at least 4 other 510(k) clearances on record.