510(k) clearances

Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)

Xuzhou Kernel Medical Equipment Co., Ltd. · Unknown

K261775Substantially EquivalentTraditional
Open FDA's page for this record
Third party flag
N
City
Xuzhou
Advisory committee description
Unknown
Address 1
Kernel Mansion, Economic Development District
Statement or summary
Summary
Zip code
221004
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Decision date
2026-07-21
Decision code
SESE
Country code
CN
Device name
Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Contact
Shanfeng Jiang
K number
K261775
Date received
2026-05-29
Review advisory committee
SU
Postal code
221004
Decision description
Substantially Equivalent
Clearance type
Traditional
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.