FDA 510(k)

F6S 全脸面罩（F6S）；P6S 鼻枕接口（P6S）

K号: K253166 · 2026-04-29

决定日期2026-04-29

产品代码BZD

咨询委员会AN 请注意，由于您没有提供完整的医疗设备监管文本，我无法提供完整的翻译。如果您能提供完整的文本，我将很乐意为您翻译。

决定实质等同

器械摘要

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is the device name listed in this FDA 510(k) record. The listed applicant is BMC Medical Co., Ltd.. It received FDA 510(k) clearance on 2026-04-29 under 510(k) number K253166. The device is classified under product code BZD. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is a medical device that received FDA 510(k) clearance on 2026-04-29. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K253166.

When did F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) receive FDA 510(k) clearance?

F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) received FDA 510(k) clearance on 2026-04-29, under 510(k) number K253166.

Who is the listed applicant for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

FDA 510(k)记录将BMC Medical Co., Ltd.列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)?

The FDA product code for F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S) is BZD.

列明BMC Medical 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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