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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 K170281
Device Name MSA100BT Peak Flow Meter
Beijing M&B Electronic Instruments Co., Ltd.
No. 27, Yongwang Road, Daxing Bioengineering and Medicine
Industry Base
beijing,  CN 101102
Applicant Contact yang shisheng
Guangzhou Osmunda Medical Device Technical Services Co.,Ltd.
8-9Th Floor, R&D Building, No.26 Qinglan St, Panyu District
guangzhou,  CN 510006
Correspondent Contact mike gu
Regulation Number868.1860
Classification Product Code
Date Received01/30/2017
Decision Date 10/06/2017
Decision substantially equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No