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FDA 510(k)

T3 Software

K-Number: K163065 · 2017-05-26

ApplicantEtiometry, Inc.
Decision Date2017-05-26
Product CodeMWI
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 2017-05-26 under 510(k) 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. The listed applicant is Etiometry, Inc.. The 510(k) number is K163065.

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

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

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 MWI.

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.

K254066Etiometry PlatformK241479Etiometry Platform (DAV 5.4 RAE 9.2)K223578T3 Platform softwareK213423T3 Platform softwareK213230T3 Platform SoftwareK202306T3 Platform software

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Related Devices (Code: MWI)

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.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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