FDA 510(k)

BH Sterilization Pouch

K号: K172280 · 2018-08-03

决定日期2018-08-03

产品代码FRG

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

BH Sterilization Pouch is the device name listed in this FDA 510(k) record. The listed applicant is Bh Medical Products Co., Ltd.. It received FDA 510(k) clearance on 2018-08-03 under 510(k) number K172280. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BH Sterilization Pouch?

BH Sterilization Pouch is a medical device that received FDA 510(k) clearance on 2018-08-03. The listed applicant is Bh Medical Products Co., Ltd.. The 510(k) number is K172280.

When did BH Sterilization Pouch receive FDA 510(k) clearance?

BH Sterilization Pouch received FDA 510(k) clearance on 2018-08-03, under 510(k) number K172280.

Who is the listed applicant for BH Sterilization Pouch?

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

What is the FDA product code for BH Sterilization Pouch?

The FDA product code for BH Sterilization Pouch is FRG.

列明Bh Medical 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。

K190484BH Medical Dental Barrier Sleeves and Barrier Film

相关器械（代码：FRG）

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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官方来源

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