Cleared Traditional

Portable Oxygen Concentrator (Model: P2-E7, P2-E)

K223379 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology
Jun 2023
Decision
227d
Days
Class 2
Risk

About This 510(k) Submission

K223379 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (Model: P2-E7, P2-E), a Generator, Oxygen, Portable (Class II — Special Controls, product code CAW), submitted by Qingdao Kingon Medical Science and Technology Co., Ltd. (Qingdao Free Trade Zone, CN). The FDA issued a Cleared decision on June 22, 2023, 227 days after receiving the submission on November 7, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K223379 FDA.gov
FDA Decision Cleared SESE
Date Received November 07, 2022
Decision Date June 22, 2023
Days to Decision 227 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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