Cleared Traditional

Drive DeVilbiss iGo 2 Portable Oxygen Concentrator

K172648 · Devilbiss Healthcare, LLC · Anesthesiology
Mar 2018
Decision
203d
Days
Class 2
Risk

About This 510(k) Submission

K172648 is an FDA 510(k) clearance for the Drive DeVilbiss iGo 2 Portable Oxygen Concentrator, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Devilbiss Healthcare, LLC (Somerset, US). The FDA issued a Cleared decision on March 23, 2018, 203 days after receiving the submission on September 1, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K172648 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2017
Decision Date March 23, 2018
Days to Decision 203 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CAW — Generator, Oxygen, Portable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5440

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