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FDA 510(k)

AURORA DIAGNOSTIC WORKSTATION

K-Number: K962589 · 1996-09-20

ApplicantAurora Technology, Inc.
Decision Date1996-09-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AURORA DIAGNOSTIC WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Technology, Inc.. It received FDA 510(k) clearance on 1996-09-20 under 510(k) number K962589. 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 AURORA DIAGNOSTIC WORKSTATION?

AURORA DIAGNOSTIC WORKSTATION is a medical device that received FDA 510(k) clearance on 1996-09-20. The listed applicant is Aurora Technology, Inc.. The 510(k) number is K962589.

When did AURORA DIAGNOSTIC WORKSTATION receive FDA 510(k) clearance?

AURORA DIAGNOSTIC WORKSTATION received FDA 510(k) clearance on 1996-09-20, under 510(k) number K962589.

Who is the listed applicant for AURORA DIAGNOSTIC WORKSTATION?

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

What is the FDA product code for AURORA DIAGNOSTIC WORKSTATION?

The FDA product code for AURORA DIAGNOSTIC WORKSTATION is LLZ.

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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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