FDA 510(k)

CryoDose V 50/50，175ml 罐装套装，CryoDose V 50/50，236ml 罐装套装

K号: K210310 · 2021-10-22

决定日期2021-10-22

产品代码GEH

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决定实质等同

器械摘要

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is the device name listed in this FDA 510(k) record. The listed applicant is Nuance Medical, LLC. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K210310. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Nuance Medical, LLC. The 510(k) number is K210310.

When did CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit receive FDA 510(k) clearance?

CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit received FDA 510(k) clearance on 2021-10-22, under 510(k) number K210310.

Who is the listed applicant for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

The FDA 510(k) record lists Nuance Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit?

The FDA product code for CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit is GEH.

列明Nuance Medical, LLC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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相关器械（代码：GEH）

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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