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FDA 510(k)

峰值流量計(PF-10(BR-PEF231))

K 號:K252802 · 2026-05-29

決定日期2026-05-29
產品代碼BZH
諮詢委員會AN
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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相關器械(代碼:BZH)

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係,請查閱連結的官方來源。

官方來源

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