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FDA 510(k)

EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)

K-Number: K053281 · 2005-12-07

ApplicantEmageon, Inc.
Decision Date2005-12-07
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) is the device name listed in this FDA 510(k) record. The listed applicant is Emageon, Inc.. It received FDA 510(k) clearance on 2005-12-07 under 510(k) number K053281. 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 EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)?

EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) is a medical device that received FDA 510(k) clearance on 2005-12-07. The listed applicant is Emageon, Inc.. The 510(k) number is K053281.

When did EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) receive FDA 510(k) clearance?

EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) received FDA 510(k) clearance on 2005-12-07, under 510(k) number K053281.

Who is the listed applicant for EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)?

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

What is the FDA product code for EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)?

The FDA product code for EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) is LLZ.

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Other records listing Emageon, Inc. as applicant

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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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