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FDA 510(k)

KINETDX

K-Number: K041029 · 2004-07-08

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2004-07-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

KINETDX is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2004-07-08 under 510(k) number K041029. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KINETDX?

KINETDX is a medical device that received FDA 510(k) clearance on 2004-07-08. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K041029.

When did KINETDX receive FDA 510(k) clearance?

KINETDX received FDA 510(k) clearance on 2004-07-08, under 510(k) number K041029.

Who is the listed applicant for KINETDX?

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

What is the FDA product code for KINETDX?

The FDA product code for KINETDX is LLZ.

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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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