FDA 510(k)

PRIME-XV FreezIS DMSO-Free MD

K号: K231804 · 2023-11-09

决定日期2023-11-09

产品代码NDS

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决定实质等同

器械摘要

PRIME-XV FreezIS DMSO-Free MD is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Irvine Scientific. It received FDA 510(k) clearance on 2023-11-09 under 510(k) number K231804. The device is classified under product code NDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PRIME-XV FreezIS DMSO-Free MD?

PRIME-XV FreezIS DMSO-Free MD is a medical device that received FDA 510(k) clearance on 2023-11-09. The listed applicant is Fujifilm Irvine Scientific. The 510(k) number is K231804.

When did PRIME-XV FreezIS DMSO-Free MD receive FDA 510(k) clearance?

PRIME-XV FreezIS DMSO-Free MD received FDA 510(k) clearance on 2023-11-09, under 510(k) number K231804.

Who is the listed applicant for PRIME-XV FreezIS DMSO-Free MD?

The FDA 510(k) record lists Fujifilm Irvine Scientific as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIME-XV FreezIS DMSO-Free MD?

The FDA product code for PRIME-XV FreezIS DMSO-Free MD is NDS.

列明Fujifilm Irvine Scientific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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