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FDA 510(k)

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS

K-Number: K033335 · 2003-11-25

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2003-11-25
Product CodeMMZ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2003-11-25 under 510(k) number K033335. The device is classified under product code MMZ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS?

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS is a medical device that received FDA 510(k) clearance on 2003-11-25. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K033335.

When did LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS receive FDA 510(k) clearance?

LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS received FDA 510(k) clearance on 2003-11-25, under 510(k) number K033335.

Who is the listed applicant for LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS?

The FDA product code for LITHOSTAR MODULARIS WITH SHOCKWAVE SYSTEM CPLUS is MMZ.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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