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FDA 510(k) Application Details - K101539
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K101539
Device Name
Oximeter
Applicant
EDAN INSTRUMENTS, INC.
NANHAI ROAD 1019#, SHEKOU,
SHENZHEN, GUANGDONG 51067 CN
Other 510(k) Applications for this Company
Contact
RANDY JIANG
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
06/03/2010
Decision Date
11/24/2010
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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