FDA 510(k)

PBM 毛发治疗帽

K号: K240472 · 2024-10-11

决定日期2024-10-11

产品代码OAP

咨询委员会PM 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

PBM Hair Therapy Cap is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240472. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PBM Hair Therapy Cap?

PBM Hair Therapy Cap is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Dongguan Tutamen Metalwork Co., Ltd.. The 510(k) number is K240472.

When did PBM Hair Therapy Cap receive FDA 510(k) clearance?

PBM Hair Therapy Cap received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240472.

Who is the listed applicant for PBM Hair Therapy Cap?

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

What is the FDA product code for PBM Hair Therapy Cap?

The FDA product code for PBM Hair Therapy Cap is OAP.

列明Dongguan Tutamen Metalwork 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。

K252439Tutamen自粘电极

相关器械（代码：OAP）

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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