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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 the device name listed in this FDA 510(k) record. The listed applicant is Etiometry, Inc.. It received FDA 510(k) clearance on 2016-03-31 under 510(k) 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. The listed applicant is Etiometry, Inc.. The 510(k) number is K152258.

When did T3 Software receive FDA 510(k) clearance?

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

Who is the listed applicant for T3 Software?

The FDA 510(k) record lists Etiometry, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for T3 Software?

The FDA product code for T3 Software is PLB.

Other records listing Etiometry, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

View all 9 devices →

Related Devices (Code: PLB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.