510(k) K261775
- Device
- Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
- Applicant
- Xuzhou Kernel Medical Equipment Co., Ltd.
- 510(k) number
- K261775
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-07-21
- Date received
- 2026-05-29
- Review panel
- Unknown
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Shanfeng Jiang
- Address
- Kernel Mansion, Economic Development District Xuzhou CN 221004 221004