FDA 510(k)

TWBM泵

K号: K180115 · 2018-07-24

决定日期2018-07-24

产品代码JCX

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决定实质等同

器械摘要

TWBM Pump is the device name listed in this FDA 510(k) record. The listed applicant is Taiwan Biomaterial Co., Ltd.. It received FDA 510(k) clearance on 2018-07-24 under 510(k) number K180115. The device is classified under product code JCX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TWBM Pump?

TWBM Pump is a medical device that received FDA 510(k) clearance on 2018-07-24. The listed applicant is Taiwan Biomaterial Co., Ltd.. The 510(k) number is K180115.

When did TWBM Pump receive FDA 510(k) clearance?

TWBM Pump received FDA 510(k) clearance on 2018-07-24, under 510(k) number K180115.

Who is the listed applicant for TWBM Pump?

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

What is the FDA product code for TWBM Pump?

The FDA product code for TWBM Pump is JCX.

列明Taiwan Biomaterial 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。

K190105ZOOM 吸痰泵

相关器械（代码：JCX）

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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