Peak Flow Meter (PF-10(BR-PEF231))— 510(k) K252802

Name: FDA 510(k) clearance K252802
Creator: U.S. Food and Drug Administration
Published: 2026-05-29

Substantially Equivalent

Shenzhen Bi-Rich Medical Devices Co., Ltd.

FDA 510(k) clearance K252802 for Peak Flow Meter (PF-10(BR-PEF231)), Substantially Equivalent on 2026-05-29. Applicant: Shenzhen Bi-Rich Medical Devices Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Bi-Rich Medical Devices Co., Ltd.
Product code: Code BZH
Device class: Class 2
Regulation: 21 CFR 868.1860
Advisory panel: Anesthesiology
Date received: 2025-09-03
Decision date: 2026-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code BZH

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K253180 — Microlife Digital Peak Flow Meter, Model PF200B (PF200B)2026-06-23
K241338 — Peak Flow Meter2024-12-31
K232588 — Aluna 22024-11-25
K230423 — Electronic Peak Flow Meter2024-02-23
K222810 — TD-7301 Peak Flow meter2023-12-19

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