FDA 510(k)

GM501 SpermAir 和 GM501 SpermActive

K号: K192644 · 2020-04-23

决定日期2020-04-23

产品代码MQL

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决定实质等同

器械摘要

GM501 SpermAir and GM501 SpermActive is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne Incorporated. It received FDA 510(k) clearance on 2020-04-23 under 510(k) number K192644. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the GM501 SpermAir and GM501 SpermActive?

GM501 SpermAir and GM501 SpermActive is a medical device that received FDA 510(k) clearance on 2020-04-23. The listed applicant is Hamilton Thorne Incorporated. The 510(k) number is K192644.

When did GM501 SpermAir and GM501 SpermActive receive FDA 510(k) clearance?

GM501 SpermAir and GM501 SpermActive received FDA 510(k) clearance on 2020-04-23, under 510(k) number K192644.

Who is the listed applicant for GM501 SpermAir and GM501 SpermActive?

The FDA 510(k) record lists Hamilton Thorne Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GM501 SpermAir and GM501 SpermActive?

The FDA product code for GM501 SpermAir and GM501 SpermActive is MQL.

列明Hamilton Thorne Incorporated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。

K192503GM501 清洗含酚红和庆大霉素

相关器械（代码：MQL）

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。

K254261玻璃化冷冻试剂盒和解冻试剂盒（CS-IVF-FK；CS-IVF-TK）CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248超快速升温Kitazato Corporation K252672CaseBio® Culture w/HSA (CMH5)；CaseBio® Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine Scientific K251637Dewin 生殖培养基（Dewin 精子缓冲液[含HSA和不含HSA]; Dewin 卵泡冲洗液，Dewin 一步法培养基[含HSA和不含HSA]）Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305超快速玻璃化；超快速温控Kitazato Corporation

官方来源

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