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FDA 510(k)

EIGEN DSA 2000

K-Number: K063846 · 2007-01-26

ApplicantEigen
Decision Date2007-01-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EIGEN DSA 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Eigen. It received FDA 510(k) clearance on 2007-01-26 under 510(k) number K063846. 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 EIGEN DSA 2000?

EIGEN DSA 2000 is a medical device that received FDA 510(k) clearance on 2007-01-26. The listed applicant is Eigen. The 510(k) number is K063846.

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

EIGEN DSA 2000 received FDA 510(k) clearance on 2007-01-26, under 510(k) number K063846.

Who is the listed applicant for EIGEN DSA 2000?

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

What is the FDA product code for EIGEN DSA 2000?

The FDA product code for EIGEN DSA 2000 is LLZ.

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Other records listing Eigen 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.

K222222Artemis, Artemis TPO, Artemis MXK173744ProFuse CADK162474ArtemisK933115DIGITAL DISK RECORDERK924164DIGITAL DISK RECORDER W/DUALPATH ARCHIVE/30-60 OPTK923585DIGITAL FLUORO STORE

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Related Devices (Code: 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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