K223740
- 510(k) number
- K223740
- Device name
- Oxygen Concentrator (Model: KSW-5, KSN-5, KSOC-5)
- Applicant
- Jiangsu Konsung Bio-Medical Science and Technology Co., Ltd. CN
- Product code
- CAW — Generator, Oxygen, Portable
- Decision date
- 2023-10-05
- Date received
- 2022-12-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Anesthesiology
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K223740
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.