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FDA 510(k)

MODIFICATION TO: AURORA

K-Number: K032678 · 2003-09-24

ApplicantAurora Imaging Technology, Inc.
Decision Date2003-09-24
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: AURORA is the device name listed in this FDA 510(k) record. The listed applicant is Aurora Imaging Technology, Inc.. It received FDA 510(k) clearance on 2003-09-24 under 510(k) number K032678. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: AURORA?

MODIFICATION TO: AURORA is a medical device that received FDA 510(k) clearance on 2003-09-24. The listed applicant is Aurora Imaging Technology, Inc.. The 510(k) number is K032678.

When did MODIFICATION TO: AURORA receive FDA 510(k) clearance?

MODIFICATION TO: AURORA received FDA 510(k) clearance on 2003-09-24, under 510(k) number K032678.

Who is the listed applicant for MODIFICATION TO: AURORA?

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

What is the FDA product code for MODIFICATION TO: AURORA?

The FDA product code for MODIFICATION TO: AURORA is LNH.

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Other records listing Aurora Imaging Technology, Inc. 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.

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Related Devices (Code: LNH)

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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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