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FDA 510(k)

T3 Platform software

K-Number: K213423 · 2023-01-06

Decision Date2023-01-06
Product CodePLB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T3 Platform software is a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2023-01-06 under approval number K213423. 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 Platform software?

T3 Platform software is a medical device that received FDA 510(k) clearance on 2023-01-06. It is manufactured by Etiometry, Inc.. The 510(k) number is K213423.

When was T3 Platform software approved by the FDA?

T3 Platform software received FDA 510(k) clearance on 2023-01-06, under approval number K213423.

What company makes T3 Platform software?

T3 Platform software is manufactured by Etiometry, Inc..

What is the FDA product code for T3 Platform software?

The FDA product code for T3 Platform software is PLB.

Related Clinical Trials

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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.