Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) 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 a medical device manufactured by Etiometry, Inc.. It received FDA 510(k) clearance on 2019-12-08 under approval 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. It is manufactured by Etiometry, Inc.. The 510(k) number is K190273.

When was T3 Platform software approved by the FDA?

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

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 MWI.

Related Clinical Trials

NCT07593872 XR-Assisted PET/CT Navigation for Cervical Lymph Node Dissection in Lung Cancer NOT_YET_RECRUITING NCT06366867 An Open Platform of Serious Games for Cognitive Intervention COMPLETED NCT02603640 " Virtual Brain "-Based Interpretation of Electrophysiological Signals in Epilepsy COMPLETED NCT06034392 CHAMP App Cardiac Study and Repository ENROLLING_BY_INVITATION NCT06052891 CHAMP For the Feeder: Tube Feeding Study ENROLLING_BY_INVITATION NCT04969757 Use of Predigraft in Kidney Transplant Patients COMPLETED

Other Devices by Etiometry, Inc.

K152258T3 Software K163065T3 Software K202306T3 Platform software K213230T3 Platform Software K223578T3 Platform software K213423T3 Platform software

View all 9 devices →

Related Devices (Code: MWI)

K161909IQvitals ZoneMidmark Corporation K160718Vital Sync Informatics Manager & Virtual Patient Monitoring PlatformCovidien K151839AMC Health VitalCaregiving SystemAmc Health K160956LD-Oxi systemLd Technology, LLC K153739MRI Patient Monitor TeslaDUOMipm Mammendorfer Institut Fur Physik Und Medizin K153225Masimo Root Monitoring System and AccessoriesMasimo Corporation

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.

↑