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FDA 510(k)

T3 Software

K-Number: K152258 · 2016-03-31

Decision Date2016-03-31
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T3 Software is a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2016-03-31 under approval number K152258. The device is classified under product code PLB. 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 2016-03-31. It is manufactured by Etiometry, Inc.. The 510(k) number is K152258.

When was T3 Software approved by the FDA?

T3 Software received FDA 510(k) clearance on 2016-03-31, under approval number K152258.

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 PLB.

Other Devices by Etiometry, Inc.

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Related Devices (Code: PLB)

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.