FDA 510(k) Application Details - K133975

Device Classification Name Meter, Peak Flow, Spirometry

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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
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Regulation Number 868.1860

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Classification Product Code BZH
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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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