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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Meter, Peak Flow, Spirometry
510(k) Number K252802
Device Name Peak Flow Meter (PF-10(BR-PEF231))
Applicant
Shenzhen Bi-Rich Medical Devices Co., Ltd.
The 1st Bldg. Of # 10, Xinqiao Gangzai Rd.
Xinqiao St., Bao'An District
Shenzhen,  CN 518125
Applicant Contact Steve Liu
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
Rm. 1801, # 161 E. Lu Jiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number868.1860
Classification Product Code
BZH  
Date Received09/03/2025
Decision Date 05/29/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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