Cleared Traditional

K190273 - T3 Platform software
(FDA 510(k) Clearance)

K190273 · Etiometry, Inc. · Cardiovascular

Dec 2019

Decision

303d

Days

Class 2

Risk

K190273 is an FDA 510(k) clearance for the T3 Platform software, a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Etiometry, Inc. (Boston, US). The FDA issued a Cleared decision on December 8, 2019, 303 days after receiving the submission on February 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K190273 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2019
Decision Date	December 08, 2019
Days to Decision	303 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300