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FDA 510(k) Application Details - K131818
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K131818
Device Name
Oximeter
Applicant
EDAN INSTRUMENTS, INC.
EQUIPMENTS PARK, NANHAI RD
1019 NO. SHEKOU NANSHAN
SHENZHEN 518067 CN
Other 510(k) Applications for this Company
Contact
QUEENA 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
06/20/2013
Decision Date
08/30/2013
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
AN - Anesthesiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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