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510(k) K252802

Peak Flow Meter (PF-10(BR-PEF231)) by Shenzhen Bi-Rich Medical Devices Co., Ltd. — Product Code BZH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 2026
Date Received
September 3, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Meter, Peak Flow, Spirometry
Device Class
Class II
Regulation Number
868.1860
Review Panel
AN
Submission Type

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