FDA 510(k)

Neuspera Nuity 系统

K号: K221303 · 2023-04-11

决定日期2023-04-11

产品代码GZF

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决定实质等同

器械摘要

Neuspera Nuity System is the device name listed in this FDA 510(k) record. The listed applicant is Neuspera Medical, Inc.. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K221303. The device is classified under product code GZF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Neuspera Nuity System?

Neuspera Nuity System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Neuspera Medical, Inc.. The 510(k) number is K221303.

When did Neuspera Nuity System receive FDA 510(k) clearance?

Neuspera Nuity System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K221303.

Who is the listed applicant for Neuspera Nuity System?

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

What is the FDA product code for Neuspera Nuity System?

The FDA product code for Neuspera Nuity System is GZF.

列明Neuspera Medical, Inc.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。

K202781Neuspera 神经刺激系统（NNS）

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