Cleared Traditional

T3 Platform software

K213423 · Etiometry, Inc. · Cardiovascular
Jan 2023
Decision
443d
Days
Class 2
Risk

About This 510(k) Submission

K213423 is an FDA 510(k) clearance for the T3 Platform software, a Multivariate Vital Signs Index (Class II — Special Controls, product code PLB), submitted by Etiometry, Inc. (Boston, US). The FDA issued a Cleared decision on January 6, 2023, 443 days after receiving the submission on October 20, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K213423 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 2021
Decision Date January 06, 2023
Days to Decision 443 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code PLB — Multivariate Vital Signs Index
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2300
Definition Automated Calculation Of A Summary Index (or Indices) Based On Several Individual Measured Vital Sign Inputs.