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FDA 510(k)

Smith & Nephew Tablet Application

K-Number: K190367 · 2019-05-21

ApplicantSmith & Nephew
Decision Date2019-05-21
Product CodeQGY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Smith & Nephew Tablet Application is a medical device manufactured by Smith & Nephew. It received FDA 510(k) clearance on 2019-05-21 under approval number K190367. The device is classified under product code QGY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Smith & Nephew Tablet Application?

Smith & Nephew Tablet Application is a medical device that received FDA 510(k) clearance on 2019-05-21. It is manufactured by Smith & Nephew. The 510(k) number is K190367.

When was Smith & Nephew Tablet Application approved by the FDA?

Smith & Nephew Tablet Application received FDA 510(k) clearance on 2019-05-21, under approval number K190367.

What company makes Smith & Nephew Tablet Application?

Smith & Nephew Tablet Application is manufactured by Smith & Nephew.

What is the FDA product code for Smith & Nephew Tablet Application?

The FDA product code for Smith & Nephew Tablet Application is QGY.

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Related PubMed Literature

PMID: 41116086 Eye-tracking-based tablet application for enhanced cognitive assessment: a clinical trial for software as a medical device (SaMD). GeroScience (2025)

Other Devices by Smith & Nephew

K153606LENS Camera Control Unit-WiFi, LENS Camera Unit-Non-WiFi, LENS camera head, Camera Coupler, Tablet Application K152686CONQUEST FN K172785CONQUEST FN K163653NOVOS-NAIL Limb Lengthening System (LLS) K201253Modular Rail System, TAYLOR SPATIAL FRAME External Fixator, JET-X Fixator, ILIZAROV External Fixator, Other External Fixation K201349Smith+Nephew Arthroscopes

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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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