FDA 510(k)

Peak Flow Meter (PF-10(BR-PEF231))

Номер K: K252802 · 2026-05-29

ЗаявительShenzhen Bi-Rich Medical Devices Co., Ltd.

Дата решения2026-05-29

Код продуктаBZH

Консультативный комитетAN

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: BZH)

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife Corporation K241338Мерник максимальной скорости потокаChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical Diagnostics K230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.

Официальный источник

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