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510(k) K223740

Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5) by Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. — Product Code CAW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2023
Date Received
December 14, 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 Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd.

  • K152091 — Fingertip Pulse Oximeter (August 18, 2016)
  • K152089 — Wrist Pulse Oximeter (August 17, 2016)

Other clearances for product code CAW

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  • K252616 — Portable oxygen concentrator (JLO-190P) (December 22, 2025)
  • K251764 — Oxygen Concentrator-P2-O5E (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)