FDA 510(k)

SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM

K-Number: K050209 · 2005-11-23

Decision Date2005-11-23

Product CodeGCJ

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM 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 2005-11-23 under 510(k) number K050209. 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 SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM?

SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM is a medical device that received FDA 510(k) clearance on 2005-11-23. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K050209.

When did SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM receive FDA 510(k) clearance?

SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM received FDA 510(k) clearance on 2005-11-23, under 510(k) number K050209.

Who is the listed applicant for SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM 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 SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM SYSTEM?

The FDA product code for SMITH & NEPHEW CONTROL DIGITAL OPERATING ROOM 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.