FDA 510(k)

真空抽吸器空气/水瓶软管

K号: K191366 · 2019-09-06

决定日期2019-09-06

产品代码OCX

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决定实质等同

器械摘要

Vacutore Air/Water Bottle Tubing is the device name listed in this FDA 510(k) record. The listed applicant is Smartdata Suzhou Co., Ltd.. It received FDA 510(k) clearance on 2019-09-06 under 510(k) number K191366. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Vacutore Air/Water Bottle Tubing?

Vacutore Air/Water Bottle Tubing is a medical device that received FDA 510(k) clearance on 2019-09-06. The listed applicant is Smartdata Suzhou Co., Ltd.. The 510(k) number is K191366.

When did Vacutore Air/Water Bottle Tubing receive FDA 510(k) clearance?

Vacutore Air/Water Bottle Tubing received FDA 510(k) clearance on 2019-09-06, under 510(k) number K191366.

Who is the listed applicant for Vacutore Air/Water Bottle Tubing?

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

What is the FDA product code for Vacutore Air/Water Bottle Tubing?

The FDA product code for Vacutore Air/Water Bottle Tubing is OCX.

列明Smartdata Suzhou 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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