510(k) K111854

AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER by St. Jude Medical Systems AB — Product Code DRG

K111854 is an FDA 510(k) premarket notification submitted by St. Jude Medical Systems AB for the device "AO USB RECEIVER, WI-BOX, WI-BOX PSU KIT, WI-BOX XPRESS CABLE, PW USB RECEIVER". The FDA issued a decision of Substantially Equivalent on October 21, 2011. The device falls under product code DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency), a Class II device regulated under 21 CFR 870.2910. St. Jude Medical Systems AB has at least 4 other 510(k) clearances on record.