Cleared Traditional

SafeT T-Piece Resuscitator

K173373 · Ventlab, LLC · Anesthesiology

Nov 2018

Decision

385d

Days

Class 2

Risk

About This 510(k) Submission

K173373 is an FDA 510(k) clearance for the SafeT T-Piece Resuscitator, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Ventlab, LLC (Grand Rapids, US). The FDA issued a Cleared decision on November 16, 2018, 385 days after receiving the submission on October 27, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number	K173373 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 27, 2017
Decision Date	November 16, 2018
Days to Decision	385 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF