FDA 510(k)

呼吸数据管理软件（PAP Link PC）

K号: K242935 · 2025-01-15

决定日期2025-01-15

产品代码BZD

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决定实质等同

器械摘要

Respiration Data Management Software (PAP Link PC) 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 2025-01-15 under 510(k) number K242935. 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 Respiration Data Management Software (PAP Link PC)?

Respiration Data Management Software (PAP Link PC) is a medical device that received FDA 510(k) clearance on 2025-01-15. The listed applicant is BMC Medical Co., Ltd.. The 510(k) number is K242935.

When did Respiration Data Management Software (PAP Link PC) receive FDA 510(k) clearance?

Respiration Data Management Software (PAP Link PC) received FDA 510(k) clearance on 2025-01-15, under 510(k) number K242935.

Who is the listed applicant for Respiration Data Management Software (PAP Link PC)?

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 Respiration Data Management Software (PAP Link PC)?

The FDA product code for Respiration Data Management Software (PAP Link PC) 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。

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）K213169BPAP 系统 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。