FDA 510(k)

DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088

K-Number: K011944 · 2001-09-19

Decision Date2001-09-19

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 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 2001-09-19 under 510(k) number K011944. 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 DIGITAL CAPTURE SYSTEM, MODEL 7209088?

DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 is a medical device that received FDA 510(k) clearance on 2001-09-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K011944.

When did DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 receive FDA 510(k) clearance?

DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 received FDA 510(k) clearance on 2001-09-19, under 510(k) number K011944.

Who is the listed applicant for DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088?

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 DIGITAL CAPTURE SYSTEM, MODEL 7209088?

The FDA product code for DYONICS VISION 635 DIGITAL CAPTURE SYSTEM, MODEL 7209088 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.