FDA 510(k)

Lotus单腔卵泡吸管针；Lotus双腔卵泡吸管针

K号: K232163 · 2024-02-22

申请人Zhejiang Horizon Medical Technology Co., Ltd.

决定日期2024-02-22

产品代码MQE

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决定实质等同

器械摘要

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is the device name listed in this FDA 510(k) record. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-02-22 under 510(k) number K232163. The device is classified under product code MQE. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is a medical device that received FDA 510(k) clearance on 2024-02-22. The listed applicant is Zhejiang Horizon Medical Technology Co., Ltd.. The 510(k) number is K232163.

When did Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle receive FDA 510(k) clearance?

Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle received FDA 510(k) clearance on 2024-02-22, under 510(k) number K232163.

Who is the listed applicant for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

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

What is the FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle?

The FDA product code for Lotus Single Lumen Ovum Aspiration Needle; Lotus Double Lumen Ovum Aspiration Needle is MQE.

列明Zhejiang Horizon Medical 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。

K223265CryoX 玻璃化冻存试剂盒/解冻试剂盒

相关器械（代码：MQE）

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。

官方来源

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