510(k) K033335

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS by Siemens Medical Solutions USA, Inc. — Product Code MMZ

K033335 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS". The FDA issued a decision of Substantially Equivalent on November 25, 2003. The device falls under product code MMZ (Table, Cystometric, Electric), a Class II device regulated under 21 CFR 876.4890. Siemens Medical Solutions USA, Inc. has at least 10 other 510(k) clearances on record.