FDA 510(k)

S-Line

K号: K182193 · 2019-01-22

决定日期2019-01-22

产品代码NJM

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决定实质等同

器械摘要

S-Line is the device name listed in this FDA 510(k) record. The listed applicant is Biocetec Co., Ltd.. It received FDA 510(k) clearance on 2019-01-22 under 510(k) number K182193. The device is classified under product code NJM. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the S-Line?

S-Line is a medical device that received FDA 510(k) clearance on 2019-01-22. The listed applicant is Biocetec Co., Ltd.. The 510(k) number is K182193.

When did S-Line receive FDA 510(k) clearance?

S-Line received FDA 510(k) clearance on 2019-01-22, under 510(k) number K182193.

Who is the listed applicant for S-Line?

The FDA 510(k) record lists Biocetec Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S-Line?

The FDA product code for S-Line is NJM.

列明Biocetec 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

在 FDA 数据库中查看 →

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。

器械摘要

常见问题

列明Biocetec Co., Ltd.为申报人的其他记录

相关器械（代码：NJM）

官方来源