510(k) K103088

GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT by Given Imaging , Ltd. — Product Code NEZ

K103088 is an FDA 510(k) premarket notification submitted by Given Imaging , Ltd. for the device "GIVEN PILLCAM PLATFORM WITH PILLCAM SB CAPSULESWITH PILLCAM R SENSORBELT". The FDA issued a decision of Substantially Equivalent on January 14, 2011. The device falls under product code NEZ (System, Imaging, Gastrointestinal, Wireless, Capsule), a Class II device regulated under 21 CFR 876.1300. Given Imaging , Ltd. has at least 10 other 510(k) clearances on record.