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FDA 510(k) Application Details - K100203
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K100203
Device Name
Oximeter
Applicant
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD.
SUITE 5D, NO. 19, LANE 999
ZHONGSHAN NO. 2 ROAD(S)
SHANGHAI 20030 CN
Other 510(k) Applications for this Company
Contact
Diana Hong
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
01/25/2010
Decision Date
05/17/2010
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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