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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 BUILDING, NO.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 BUILDING, NO.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
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