510(k) K050411

ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM by Zimmer, Inc. — Product Code KCY

K050411 is an FDA 510(k) premarket notification submitted by Zimmer, Inc. for the device "ZIMMER A.T.S. 3000 AUTOMATIC TOURNIQUET SYSTEM". The FDA issued a decision of Substantially Equivalent on September 2, 2005. The device falls under product code KCY (Tourniquet, Pneumatic), a Class I device regulated under 21 CFR 878.5910. Zimmer, Inc. has at least 10 other 510(k) clearances on record.