Cleared Traditional

T3 Software

K152258 · Etiometry, Inc. · Cardiovascular
Mar 2016
Decision
233d
Days
Class 2
Risk

About This 510(k) Submission

K152258 is an FDA 510(k) clearance for the T3 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 March 31, 2016, 233 days after receiving the submission on August 11, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number K152258 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2015
Decision Date March 31, 2016
Days to Decision 233 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.