Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

T3 Platform software

K-Number: K190273 · 2019-12-08

ApplicantEtiometry, Inc.
Decision Date2019-12-08
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

T3 Platform 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 2019-12-08 under 510(k) number K190273. 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 Platform software?

T3 Platform software is a medical device that received FDA 510(k) clearance on 2019-12-08. The listed applicant is Etiometry, Inc.. The 510(k) number is K190273.

When did T3 Platform software receive FDA 510(k) clearance?

T3 Platform software received FDA 510(k) clearance on 2019-12-08, under 510(k) number K190273.

Who is the listed applicant for T3 Platform 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 Platform software?

The FDA product code for T3 Platform 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

View all 9 devices →

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.

K260438Vital Signs Monitor (CLEO2)Infinium Medical, Inc.K253417Masimo Root Monitoring SystemMasimo CorporationK253196Midmark 800 Digital Vital Signs Device (1-300-0100, 1-300-0200, 1-300-0300, 1-300-0400)Midmark CorporationK253436c-med0 alphaCosinuss GmbHK250135WAVE Clinical Platform (2.0.000)Baxter Healthcare Corp/ Excel MedicalK241766QMAPP® (Hemo, Hemo Lite, PCM, GO, Hybrid)Fysicon BV

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.

↑