510(k) K061685

PULSERA by Philips Medical Systems North America Co. — Product Code IZL

K061685 is an FDA 510(k) premarket notification submitted by Philips Medical Systems North America Co. for the device "PULSERA". The FDA issued a decision of Substantially Equivalent on September 15, 2006. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Philips Medical Systems North America Co. has at least 10 other 510(k) clearances on record.