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FDA 510(k)

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

K-Number: K252802 · 2026-05-29

ApplicantShenzhen Bi-Rich Medical Devices Co., Ltd.
Decision Date2026-05-29
Product CodeBZH
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: BZH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253180Microlife Digital Peak Flow Meter, Model PF200B (PF200B)Microlife CorporationK241338Peak Flow MeterChongqing Moffy Innovation Technology Co., Ltd.K232588Aluna 2Knox Medical DiagnosticsK230423Electronic Peak Flow MeterTaian Dalu Medical Instrument Co., Ltd.K222810TD-7301 Peak Flow meterGostar Co., Ltd.K203196Peak flow meterShanghai Sonmol Medical Equipment Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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