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FDA 510(k) Application Details - K082487
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K082487
Device Name
Oximeter
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
ROOM 1127-1128 BUILDING B
BAILANGYUAN FUXING RD. #A36
BEIJING 100039 CN
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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
08/28/2008
Decision Date
03/04/2009
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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