Cleared Traditional

Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)

K230702 · Qingdao Kingon Medical Science and Technology Co., Ltd. · Anesthesiology
Oct 2023
Decision
218d
Days
Class 2
Risk

About This 510(k) Submission

K230702 is an FDA 510(k) clearance for the Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3), 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 October 18, 2023, 218 days after receiving the submission on March 14, 2023. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5440.

Submission Details

510(k) Number K230702 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2023
Decision Date October 18, 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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