FDA 510(k)

handLITE（TN19S）

K号: K250224 · 2025-04-18

决定日期2025-04-18

产品代码ONE

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决定实质等同

器械摘要

handLITE (TN19S) is the device name listed in this FDA 510(k) record. The listed applicant is iSMART Developments, Ltd.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250224. The device is classified under product code ONE. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the handLITE (TN19S)?

handLITE (TN19S) is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is iSMART Developments, Ltd.. The 510(k) number is K250224.

When did handLITE (TN19S) receive FDA 510(k) clearance?

handLITE (TN19S) received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250224.

Who is the listed applicant for handLITE (TN19S)?

FDA 510(k)记录将iSMART Developments, Ltd.列为申请人。这本身并不能确立该设备的制造商。

What is the FDA product code for handLITE (TN19S)?

The FDA product code for handLITE (TN19S) is ONE.

列明iSMART Developments, Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。