FDA 510(k)

EsCom250

K号: K231523 · 2023-07-24

决定日期2023-07-24

产品代码EBF

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决定实质等同

器械摘要

EsCom250 is the device name listed in this FDA 510(k) record. The listed applicant is Spident Co., Ltd.. It received FDA 510(k) clearance on 2023-07-24 under 510(k) number K231523. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EsCom250?

EsCom250 is a medical device that received FDA 510(k) clearance on 2023-07-24. The listed applicant is Spident Co., Ltd.. The 510(k) number is K231523.

When did EsCom250 receive FDA 510(k) clearance?

EsCom250 received FDA 510(k) clearance on 2023-07-24, under 510(k) number K231523.

Who is the listed applicant for EsCom250?

FDA 510(k)记录将Spident Co., Ltd.列为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for EsCom250?

The FDA product code for EsCom250 is EBF.

列明Spident Co., 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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