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FDA 510(k) Application Details - K140682
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K140682
Device Name
Oximeter
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
NO. 9 SHUANGYUAN ROAD, BADACHU HI-TECH ZONE
SHIJINGSHAN DISTRICT
BEIJING 100041 CN
Other 510(k) Applications for this Company
Contact
LEI CHEN
Other 510(k) Applications for this Contact
Regulation Number
870.2700
More FDA Info for this Regulation Number
Classification Product Code
DQA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/18/2014
Decision Date
07/17/2014
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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