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FDA 510(k)

ULTRAVISUAL

K-Number: K042008 · 2004-09-03

ApplicantEmageon Uv, Inc.
Decision Date2004-09-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ULTRAVISUAL is the device name listed in this FDA 510(k) record. The listed applicant is Emageon Uv, Inc.. It received FDA 510(k) clearance on 2004-09-03 under 510(k) number K042008. 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 ULTRAVISUAL?

ULTRAVISUAL is a medical device that received FDA 510(k) clearance on 2004-09-03. The listed applicant is Emageon Uv, Inc.. The 510(k) number is K042008.

When did ULTRAVISUAL receive FDA 510(k) clearance?

ULTRAVISUAL received FDA 510(k) clearance on 2004-09-03, under 510(k) number K042008.

Who is the listed applicant for ULTRAVISUAL?

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

What is the FDA product code for ULTRAVISUAL?

The FDA product code for ULTRAVISUAL is 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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