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FDA 510(k) Application Details - K172366
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K172366
Device Name
Oximeter
Applicant
Beijing Choice Electronic Technology Co., Ltd.
No.9 Shuangyuan road, Badachu Hi-tech Zone, Shijingshan Dist
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
08/04/2017
Decision Date
03/16/2018
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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