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FDA 510(k)

SMITH & NEPHEW CDS SYSTEM

K-Number: K081491 · 2008-06-19

ApplicantSmith & Nephew, Inc.
Decision Date2008-06-19
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW CDS 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 2008-06-19 under 510(k) number K081491. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW CDS SYSTEM?

SMITH & NEPHEW CDS SYSTEM is a medical device that received FDA 510(k) clearance on 2008-06-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K081491.

When did SMITH & NEPHEW CDS SYSTEM receive FDA 510(k) clearance?

SMITH & NEPHEW CDS SYSTEM received FDA 510(k) clearance on 2008-06-19, under 510(k) number K081491.

Who is the listed applicant for SMITH & NEPHEW CDS 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 CDS SYSTEM?

The FDA product code for SMITH & NEPHEW CDS SYSTEM is JAA.

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Other records listing Smith & Nephew, 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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