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FDA 510(k)

T3 Software

K-Number: K163065 · 2017-05-26

Decision Date2017-05-26
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T3 Software is a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2017-05-26 under approval number K163065. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the T3 Software?

T3 Software is a medical device that received FDA 510(k) clearance on 2017-05-26. It is manufactured by Etiometry, Inc.. The 510(k) number is K163065.

When was T3 Software approved by the FDA?

T3 Software received FDA 510(k) clearance on 2017-05-26, under approval number K163065.

What company makes T3 Software?

T3 Software is manufactured by Etiometry, Inc..

What is the FDA product code for T3 Software?

The FDA product code for T3 Software is MWI.

Other Devices by Etiometry, Inc.

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Related Devices (Code: MWI)

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.