Cleared Traditional

Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A

K213825 · Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. · Anesthesiology
Apr 2023
Decision
506d
Days
Class 2
Risk

About This 510(k) Submission

K213825 is an FDA 510(k) clearance for the Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Jiangsu Yuyue Medical Equipment& Supply Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on April 28, 2023, 506 days after receiving the submission on December 8, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K213825 FDA.gov
FDA Decision Cleared SESE
Date Received December 08, 2021
Decision Date April 28, 2023
Days to Decision 506 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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