Cleared Traditional

VORTRAN GO2VENT with PEEP Valve

K202219 · Vortran Medical Technology 1, Inc. · Anesthesiology
Feb 2021
Decision
189d
Days
Class 2
Risk

About This 510(k) Submission

K202219 is an FDA 510(k) clearance for the VORTRAN GO2VENT with PEEP Valve, 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 February 11, 2021, 189 days after receiving the submission on August 6, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5925.

Submission Details

510(k) Number K202219 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2020
Decision Date February 11, 2021
Days to Decision 189 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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