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FDA 510(k)

INFINITY EXPLORER

K-Number: K030615 · 2003-03-21

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2003-03-21
Product CodeMSX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INFINITY EXPLORER 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 2003-03-21 under 510(k) number K030615. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY EXPLORER?

INFINITY EXPLORER is a medical device that received FDA 510(k) clearance on 2003-03-21. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K030615.

When did INFINITY EXPLORER receive FDA 510(k) clearance?

INFINITY EXPLORER received FDA 510(k) clearance on 2003-03-21, under 510(k) number K030615.

Who is the listed applicant for INFINITY EXPLORER?

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 INFINITY EXPLORER?

The FDA product code for INFINITY EXPLORER is MSX.

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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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