Cleared Traditional

VORTRAN GO2VENT

K162968 · Vortran Medical Technology 1, Inc. · Anesthesiology
Apr 2017
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K162968 is an FDA 510(k) clearance for the VORTRAN GO2VENT, a Ventilator, Emergency, Powered (resuscitator) (Class II — Special Controls, product code BTL), submitted by Vortran Medical Technology 1, Inc. (Sacramento, US). The FDA issued a Cleared decision on April 10, 2017, 168 days after receiving the submission on October 24, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K162968 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 2016
Decision Date April 10, 2017
Days to Decision 168 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BTL — Ventilator, Emergency, Powered (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5925

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