FDA 510(k)

SignalNED 系统（型号 RE）

K号: K251726 · 2025-09-03

决定日期2025-09-03

产品代码OMC

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决定实质等同

器械摘要

SignalNED System (Model RE) is the device name listed in this FDA 510(k) record. The listed applicant is Forest Devices, Inc.. It received FDA 510(k) clearance on 2025-09-03 under 510(k) number K251726. The device is classified under product code OMC. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SignalNED System (Model RE)?

SignalNED System (Model RE) is a medical device that received FDA 510(k) clearance on 2025-09-03. The listed applicant is Forest Devices, Inc.. The 510(k) number is K251726.

When did SignalNED System (Model RE) receive FDA 510(k) clearance?

SignalNED System (Model RE) received FDA 510(k) clearance on 2025-09-03, under 510(k) number K251726.

Who is the listed applicant for SignalNED System (Model RE)?

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

What is the FDA product code for SignalNED System (Model RE)?

The FDA product code for SignalNED System (Model RE) is OMC.

列明Forest Devices, 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。

K242306SignalNED 系统（型号 RE）

官方来源

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