Cleared Traditional

YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B

K083559 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology
Sep 2009
Decision
276d
Days
Class 2
Risk

About This 510(k) Submission

K083559 is an FDA 510(k) clearance for the YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Potomac, US). The FDA issued a Cleared decision on September 4, 2009, 276 days after receiving the submission on December 2, 2008. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K083559 FDA.gov
FDA Decision Cleared SESE
Date Received December 02, 2008
Decision Date September 04, 2009
Days to Decision 276 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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