FDA 510(k)

RED光设备

K号: K162489 · 2017-01-13

申请人Zhongshan Bisen Plastic Electronic Products Co., Ltd.

决定日期2017-01-13

产品代码OHS

咨询委员会SU 请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。

决定实质等同

器械摘要

RED Light Device is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Bisen Plastic Electronic Products Co., Ltd.. It received FDA 510(k) clearance on 2017-01-13 under 510(k) number K162489. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RED Light Device?

RED Light Device is a medical device that received FDA 510(k) clearance on 2017-01-13. The listed applicant is Zhongshan Bisen Plastic Electronic Products Co., Ltd.. The 510(k) number is K162489.

When did RED Light Device receive FDA 510(k) clearance?

RED Light Device received FDA 510(k) clearance on 2017-01-13, under 510(k) number K162489.

Who is the listed applicant for RED Light Device?

The FDA 510(k) record lists Zhongshan Bisen Plastic Electronic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RED Light Device?

The FDA product code for RED Light Device is OHS.

列明Zhongshan Bisen Plastic Electronic Products 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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相关器械（代码：OHS）

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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