FDA 510(k)

Sunny Plus (Sunny)

K号: K251649 · 2025-09-18

决定日期2025-09-18

产品代码NFO

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决定实质等同

器械摘要

Sunny Plus (Sunny) is the device name listed in this FDA 510(k) record. The listed applicant is ShenB Co., Ltd.. It received FDA 510(k) clearance on 2025-09-18 under 510(k) number K251649. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Sunny Plus (Sunny)?

Sunny Plus (Sunny) is a medical device that received FDA 510(k) clearance on 2025-09-18. The listed applicant is ShenB Co., Ltd.. The 510(k) number is K251649.

When did Sunny Plus (Sunny) receive FDA 510(k) clearance?

Sunny Plus (Sunny) received FDA 510(k) clearance on 2025-09-18, under 510(k) number K251649.

Who is the listed applicant for Sunny Plus (Sunny)?

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

What is the FDA product code for Sunny Plus (Sunny)?

The FDA product code for Sunny Plus (Sunny) is NFO.

列明ShenB 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。

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