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FDA 510(k)

DEXIS SOFTWARE

K-Number: K090431 · 2009-06-22

ApplicantDexis, LLC
Decision Date2009-06-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DEXIS SOFTWARE is the device name listed in this FDA 510(k) record. The listed applicant is Dexis, LLC. It received FDA 510(k) clearance on 2009-06-22 under 510(k) number K090431. 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 DEXIS SOFTWARE?

DEXIS SOFTWARE is a medical device that received FDA 510(k) clearance on 2009-06-22. The listed applicant is Dexis, LLC. The 510(k) number is K090431.

When did DEXIS SOFTWARE receive FDA 510(k) clearance?

DEXIS SOFTWARE received FDA 510(k) clearance on 2009-06-22, under 510(k) number K090431.

Who is the listed applicant for DEXIS SOFTWARE?

The FDA 510(k) record lists Dexis, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEXIS SOFTWARE?

The FDA product code for DEXIS SOFTWARE is LLZ.

Related Clinical Trials

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Other records listing Dexis, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K090458DEXIS SENSOR

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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