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FDA 510(k)

Microlife 数字峰值流量计,型号 PF200B (PF200B)

K号: K253180 · 2026-06-23

决定日期2026-06-23
产品代码BZH
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

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is the device name listed in this FDA 510(k) record. The listed applicant is Microlife Corporation. It received FDA 510(k) clearance on 2026-06-23 under 510(k) number K253180. The device is classified under product code BZH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is a medical device that received FDA 510(k) clearance on 2026-06-23. The listed applicant is Microlife Corporation. The 510(k) number is K253180.

When did Microlife Digital Peak Flow Meter, Model PF200B (PF200B) receive FDA 510(k) clearance?

Microlife Digital Peak Flow Meter, Model PF200B (PF200B) received FDA 510(k) clearance on 2026-06-23, under 510(k) number K253180.

Who is the listed applicant for Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

FDA 510(k)记录显示Microlife Corporation为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for Microlife Digital Peak Flow Meter, Model PF200B (PF200B)?

The FDA product code for Microlife Digital Peak Flow Meter, Model PF200B (PF200B) is BZH.

相关临床试验

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。

列明Microlife Corporation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。

相关器械(代码:BZH)

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。

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。

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