Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
FDA 510(k) clearance K230702 · decided 2023-10-18
Clearance details
- K-number
- K230702
- Device name
- Portable Oxygen Concentrator (Model: P2-S4, P2-S3,P2-K4,P2-K3)
- Applicant
- Qingdao Kingon Medical Science and Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-14
- Decision date
- 2023-10-18
- Days to decision
- 218 days
- Clearance type
- Traditional
- Product code
- CAW
- Device class
- 2
- Regulation number
- 868.5440
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Qingdao Free Trade Zone, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.