FDA 510(k)

N7-S

K号: K240168 · 2024-09-12

决定日期2024-09-12

产品代码JFB

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决定实质等同

器械摘要

N7-S is the device name listed in this FDA 510(k) record. The listed applicant is Nuga Medical Co., Ltd.. It received FDA 510(k) clearance on 2024-09-12 under 510(k) number K240168. The device is classified under product code JFB. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the N7-S?

N7-S is a medical device that received FDA 510(k) clearance on 2024-09-12. The listed applicant is Nuga Medical Co., Ltd.. The 510(k) number is K240168.

When did N7-S receive FDA 510(k) clearance?

N7-S received FDA 510(k) clearance on 2024-09-12, under 510(k) number K240168.

Who is the listed applicant for N7-S?

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

What is the FDA product code for N7-S?

The FDA product code for N7-S is JFB.

列明Nuga Medical 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。

K153054N5-1

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

器械摘要

常见问题

列明Nuga Medical Co., Ltd.为申报人的其他记录

相关器械（代码：JFB）

官方来源