510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261775Substantially Equivalent

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

Xuzhou Kernel Medical Equipment Co Ltd, Xuzhou, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K261775 is the FDA 510(k) clearance record for Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB), cleared for Xuzhou Kernel Medical Equipment Co., Ltd. on . FDA records list 9 510(k) clearances for Xuzhou Kernel Medical Equipment Co., Ltd., from to . As of , FDA records show no recalls naming K261775.

Clearance record

Decision date
Received
(53 days to decision)
Review panel
Unknown
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd. Kernel Mansion, Economic Development District, Xuzhou, CN
510(k) summary
Summary PDF
Third party review
No