FDA 510(k)

沸石止血棉

K号: K223495 · 2023-05-02

申请人Hangzhou Zeo-Innov Life Technology Co., Ltd.

决定日期2023-05-02

产品代码QSY

决定实质等同

器械摘要

Zeolite Hemostatic Cotton is the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-05-02 under 510(k) number K223495. The device is classified under product code QSY. FDA Decision: Substantially Equivalent.

常见问题

What is the Zeolite Hemostatic Cotton?

Zeolite Hemostatic Cotton is a medical device that received FDA 510(k) clearance on 2023-05-02. The listed applicant is Hangzhou Zeo-Innov Life Technology Co., Ltd.. The 510(k) number is K223495.

When did Zeolite Hemostatic Cotton receive FDA 510(k) clearance?

Zeolite Hemostatic Cotton received FDA 510(k) clearance on 2023-05-02, under 510(k) number K223495.

Who is the listed applicant for Zeolite Hemostatic Cotton?

The FDA 510(k) record lists Hangzhou Zeo-Innov Life Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Zeolite Hemostatic Cotton?

The FDA product code for Zeolite Hemostatic Cotton is QSY.

列明Hangzhou Zeo-Innov Life Technology 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。

K211570沸石止血纱布

相关器械（代码：QSY）

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。

K253017BloodSTOP iX Trauma Matrix (TM-iX-20)Lifescience Plus, Inc.K251700Ganymede 2cm直径（FG100300）；Ganymede 5cm x 5cm（FG100400）；Ganymede 10cm x 10cm（FG100500）；Ganymede 15cm x 15cm（FG100600）；Ganymede 20cm x 30cm（FG100700）；Ganymede 25cm x 25cm（FG100800）；Ganymede 30cm x 30cm（FG100900）；Ganymede 40cm x 40cm （FG100999）；Ganymede 7.5cm x 120cm（FG100100）；Ganymede-X 2cm直径（FG100301）；Ganymede-X 5cm x 5cm（FG100401）；Ganymede-X 10cm x 10cm（FG100501）；Ganymede-X 15cm x 15cm（FG100601）；Ganymede-X 20cm x 30cm （FG100701）；Ganymede-X 25cmSpeciality Fibres and Materials Limited K250319MFUSE (MS001)Machina Medical, Inc.K253609TRAUMAGEL® 2.0 止血凝胶Cresilon, Inc.K240713TRAUMAGEL®Cresilon, Inc.K240097多糖止血粉（HP-2，HP-3，HP-5）Ushare Medical, Inc.

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