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FDA 510(k)

INTELLIO Tablet Application

K-Number: K192876 · 2020-02-27

Decision Date2020-02-27
Product CodeODA
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

INTELLIO Tablet Application is a medical device manufactured by Smith & Nephew. It received FDA 510(k) clearance on 2020-02-27 under approval number K192876. The device is classified under product code ODA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIO Tablet Application?

INTELLIO Tablet Application is a medical device that received FDA 510(k) clearance on 2020-02-27. It is manufactured by Smith & Nephew. The 510(k) number is K192876.

When was INTELLIO Tablet Application approved by the FDA?

INTELLIO Tablet Application received FDA 510(k) clearance on 2020-02-27, under approval number K192876.

What company makes INTELLIO Tablet Application?

INTELLIO Tablet Application is manufactured by Smith & Nephew.

What is the FDA product code for INTELLIO Tablet Application?

The FDA product code for INTELLIO Tablet Application is ODA.

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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.