FDA 510(k)

BPAP 系统

K号: K213169 · 2022-12-05

决定日期2022-12-05

产品代码MNS

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决定实质等同

器械摘要

BPAP System 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 2022-12-05 under 510(k) number K213169. The device is classified under product code MNS. It was reviewed by the AN advisory panel. Product code MNS falls under the category of Neurology, which encompasses devices for neurological diagnosis and monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the BPAP System?

BPAP System is a medical device that received FDA 510(k) clearance on 2022-12-05. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K213169.

When did BPAP System receive FDA 510(k) clearance?

BPAP System received FDA 510(k) clearance on 2022-12-05, under 510(k) number K213169.

Who is the listed applicant for BPAP System?

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 BPAP System?

The FDA product code for BPAP System is MNS. This falls under the Neurology category.

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。

K260171便携式氧气浓缩器（PO1 5B，PO1 6B）K253166F6S 全脸面罩（F6S）；P6S 鼻枕接口（P6S）K242935呼吸数据管理软件（PAP Link PC）K211155Auto CPAP 系统

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。