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510(k) K223379

Portable Oxygen Concentrator (Model: P2-E7, P2-E) by Qingdao Kingon Medical Science and Technology Co., Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 2023
Date Received
November 7, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Generator, Oxygen, Portable
Device Class
Class II
Regulation Number
868.5440
Review Panel
AN
Submission Type

Other clearances by Qingdao Kingon Medical Science and Technology Co., Ltd.

  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K242718 — Portable Oxygen Concentrator (P2-TOC) (February 28, 2025)
  • K230702 — Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3) (October 18, 2023)
  • K210371 — Portable Oxygen Concentrator, model: P2-E6 (June 3, 2022)

Other clearances for product code CAW

  • K251534 — Oxygen Concentrator (J10A) (December 29, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (December 22, 2025)
  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K252268 — V series portable oxygen concentrator (V5, V5C, V6, V6C) (December 16, 2025)
  • K250805 — DeVilbiss PulmO2 10-Liter Oxygen Concentrator (1060AW) (December 9, 2025)
  • K251607 — Oxygen Concentrator (J5A) (November 21, 2025)
  • K243833 — Portable oxygen concentrator (JAY-1000P) (September 29, 2025)
  • K250625 — Portable oxygen concentrator (W-R1(MAX)); Portable oxygen concentrator (W-R1); (August 27, 2025)
  • K251130 — Portable Oxygen Concentrator (JM-P50A) (August 21, 2025)
  • K250671 — FreeStyle Comfort (AS200 / FreeStyle Comfort) (July 11, 2025)