峰值流量计（PF-10(BR-PEF231)）
K号: K252802 · 2026-05-29
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决定日期2026-05-29
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
Peak Flow Meter (PF-10(BR-PEF231)) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Bi-Rich Medical Devices Co., Ltd.. It received FDA 510(k) clearance on 2026-05-29 under 510(k) number K252802. 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 Peak Flow Meter (PF-10(BR-PEF231))?
Peak Flow Meter (PF-10(BR-PEF231)) is a medical device that received FDA 510(k) clearance on 2026-05-29. The listed applicant is Shenzhen Bi-Rich Medical Devices Co., Ltd.. The 510(k) number is K252802.
When did Peak Flow Meter (PF-10(BR-PEF231)) receive FDA 510(k) clearance?
Peak Flow Meter (PF-10(BR-PEF231)) received FDA 510(k) clearance on 2026-05-29, under 510(k) number K252802.
Who is the listed applicant for Peak Flow Meter (PF-10(BR-PEF231))?
The FDA 510(k) record lists Shenzhen Bi-Rich Medical Devices Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Peak Flow Meter (PF-10(BR-PEF231))?
The FDA product code for Peak Flow Meter (PF-10(BR-PEF231)) 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。
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。
K253180Microlife 数字峰值流量计，型号 PF200B (PF200B)Microlife CorporationK241338峰值流量计Chongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423电子峰值流量计Taian Dalu Medical Instrument Co., Ltd.K222810TD-7301 峰值流量计Gostar Co., Ltd.K203196峰值流量计Shanghai Sonmol Medical Equipment Co., Ltd.
官方来源
在 FDA 数据库中查看 →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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