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FDA 510(k)

IMAGE MANAGEMENT SYSTEM

K-Number: K033870 · 2004-03-12

ApplicantWelch Allyn, Inc.
Decision Date2004-03-12
Product CodeHEX
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

IMAGE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Welch Allyn, Inc.. It received FDA 510(k) clearance on 2004-03-12 under 510(k) number K033870. The device is classified under product code HEX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMAGE MANAGEMENT SYSTEM?

IMAGE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-03-12. The listed applicant is Welch Allyn, Inc.. The 510(k) number is K033870.

When did IMAGE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2004-03-12, under 510(k) number K033870.

Who is the listed applicant for IMAGE MANAGEMENT SYSTEM?

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

What is the FDA product code for IMAGE MANAGEMENT SYSTEM?

The FDA product code for IMAGE MANAGEMENT SYSTEM is HEX.

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Other records listing Welch Allyn, 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: HEX)

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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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