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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 K133975
Device Name MSA100 PEAK FLOW METER
Applicant
Beijing M&B Electronic Instruments Co., Ltd.
7th Floor, Jingui Business Bldg., #982 Congyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Applicant Contact MIKE GU
Correspondent
Beijing M&B Electronic Instruments Co., Ltd.
7th Floor, Jingui Business Bldg., #982 Congyun Rd.
Baiyun District
Guangzhou, Guangdong,  CN 510420
Correspondent Contact MIKE GU
Regulation Number868.1860
Classification Product Code
BZH  
Date Received12/26/2013
Decision Date 10/03/2014
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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