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FDA 510(k) Application Details - K133975
Device Classification Name
Meter, Peak Flow, Spirometry
More FDA Info for this Device
510(K) Number
K133975
Device Name
Meter, Peak Flow, Spirometry
Applicant
BEIJING M&B ELECTRONIC INSTRUMENTS, CO., LTD
7TH FLOOR, JINGUI BUSINESS BUILDING, NO.982 CONGYUN RD
BAIYUN DISTRICT
GUANGZHOU, GUANGDONG 510420 CN
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Contact
MIKE GU
Other 510(k) Applications for this Contact
Regulation Number
868.1860
More FDA Info for this Regulation Number
Classification Product Code
BZH
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More FDA Info for this Product Code
Date Received
12/26/2013
Decision Date
10/03/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
AN - Anesthesiology
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
FDA Source Information for K133975
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