Cleared Traditional

Oxygen Concentrator

K230969 · Jiangsu Jumao X-Care Medical Equipment Co., Ltd. · Anesthesiology
Nov 2023
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K230969 is an FDA 510(k) clearance for the Oxygen Concentrator, a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Jiangsu Jumao X-Care Medical Equipment Co., Ltd. (Danyang, CN). The FDA issued a Cleared decision on November 9, 2023, 218 days after receiving the submission on April 5, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K230969 FDA.gov
FDA Decision Cleared SESE
Date Received April 05, 2023
Decision Date November 09, 2023
Days to Decision 218 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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