FDA 510(k)

Nurochek-Pro 系统

K号: K243426 · 2025-03-27

决定日期2025-03-27

产品代码PIW

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决定实质等同

器械摘要

Nurochek-Pro System is the device name listed in this FDA 510(k) record. The listed applicant is Headsafe Mfg Pty, Ltd.. It received FDA 510(k) clearance on 2025-03-27 under 510(k) number K243426. The device is classified under product code PIW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Nurochek-Pro System?

Nurochek-Pro System is a medical device that received FDA 510(k) clearance on 2025-03-27. The listed applicant is Headsafe Mfg Pty, Ltd.. The 510(k) number is K243426.

When did Nurochek-Pro System receive FDA 510(k) clearance?

Nurochek-Pro System received FDA 510(k) clearance on 2025-03-27, under 510(k) number K243426.

Who is the listed applicant for Nurochek-Pro System?

The FDA 510(k) record lists Headsafe Mfg Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Nurochek-Pro System?

The FDA product code for Nurochek-Pro System is PIW.

列明Headsafe Mfg Pty, 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。

K231914Nurochek-II 系统

官方来源

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