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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 K230423
Device Name Electronic Peak Flow Meter
Applicant
Taian Dalu Medical Instrument Co., Ltd.
West Part Of Yitianmen St., Hi-Tech Zone
Taian City,  CN 271000
Applicant Contact Wang Yuqin
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
1713a, 17th Floor, Block A, Zhongguan Times Sq.
Liuxian Ave., Xili Town, Nanshan District
Shenzhen,  CN 518000
Correspondent Contact Liz Li
Regulation Number868.1860
Classification Product Code
BZH  
Date Received02/17/2023
Decision Date 02/23/2024
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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