FDA 510(k)

DSA 2000EX

K-Number: K082341 · 2008-08-29

Decision Date2008-08-29

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

DSA 2000EX is the device name listed in this FDA 510(k) record. The listed applicant is Eigen, LLC. It received FDA 510(k) clearance on 2008-08-29 under 510(k) number K082341. 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 DSA 2000EX?

DSA 2000EX is a medical device that received FDA 510(k) clearance on 2008-08-29. The listed applicant is Eigen, LLC. The 510(k) number is K082341.

When did DSA 2000EX receive FDA 510(k) clearance?

DSA 2000EX received FDA 510(k) clearance on 2008-08-29, under 510(k) number K082341.

Who is the listed applicant for DSA 2000EX?

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

What is the FDA product code for DSA 2000EX?

The FDA product code for DSA 2000EX is LLZ.

Other records listing Eigen, 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.

K0810933-D IMAGING WORKSTATION

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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.