510(k) K070718

MODIFICATION TO: BODYGUARD INFUSION SYSTEM by Caesarea Medical Electronics , Ltd. — Product Code FRN

K070718 is an FDA 510(k) premarket notification submitted by Caesarea Medical Electronics , Ltd. for the device "MODIFICATION TO: BODYGUARD INFUSION SYSTEM". The FDA issued a decision of Substantially Equivalent on April 13, 2007. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Caesarea Medical Electronics , Ltd. has at least 8 other 510(k) clearances on record.