510(k) K052221

AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP by Sorenson Medical, Inc. — Product Code FRN

K052221 is an FDA 510(k) premarket notification submitted by Sorenson Medical, Inc. for the device "AMBIT PUSH & PLAY AMBULATORY INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on December 8, 2005. The device falls under product code FRN (Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Sorenson Medical, Inc. has at least 5 other 510(k) clearances on record.