FDA 510(k)

DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM

K-Number: K023053 · 2002-10-03

Decision Date2002-10-03

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2002-10-03 under 510(k) number K023053. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM?

DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2002-10-03. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K023053.

When did DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM receive FDA 510(k) clearance?

DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM received FDA 510(k) clearance on 2002-10-03, under 510(k) number K023053.

Who is the listed applicant for DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM?

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

What is the FDA product code for DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM?

The FDA product code for DYONICS VISION 635 IMAGE MANAGEMENT SYSTEM is GCJ.

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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.