FDA 510(k)

ZOOM 吸痰泵

K号: K190105 · 2019-02-21

决定日期2019-02-21

产品代码JCX

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决定实质等同

器械摘要

ZOOM Aspiration 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 2019-02-21 under 510(k) number K190105. 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 ZOOM Aspiration Pump?

ZOOM Aspiration Pump is a medical device that received FDA 510(k) clearance on 2019-02-21. The listed applicant is Taiwan Biomaterial Co., Ltd.. The 510(k) number is K190105.

When did ZOOM Aspiration Pump receive FDA 510(k) clearance?

ZOOM Aspiration Pump received FDA 510(k) clearance on 2019-02-21, under 510(k) number K190105.

Who is the listed applicant for ZOOM Aspiration 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 ZOOM Aspiration Pump?

The FDA product code for ZOOM Aspiration 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。

K180115TWBM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。

K250964便携式痰液吸引器（JMA D01）Jiangsu Jumao X-Care Medical Equipment Co., Ltd.K243638MV Flow 吸引泵（MVFLOWPMP01）Microvention K251111CaryExcitus AS K243418Riptide™ 吸引泵；Riptide™ 收集罐与中间软管Micro Therapeutics, Inc. d/b/a ev3 Neurovascular K233428Easycess 吸引泵Guangzhou Easycess Medical Co.,Ltd K222552120V Neptune S Rover (0711-001-000)；V2 4-端口歧管 (0750-400-000)；V2 标本收集歧管套装 (0750-200-000)；V2 标本收集托盘 (0750-210-000)Stryker Instruments

官方来源

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