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FDA 510(k) Application Details - K162580
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K162580
Device Name
Oximeter
Applicant
TAIWAN AULISA MEDICAL DEVICES TECHNOLOGIES, INC.
RM. 1052, BLDG.H, 10F., NO.3-2, YUANQU ST., NANGANG DIST.
TAIPEI CITY 115 TW
Other 510(k) Applications for this Company
Contact
ALAN TANG
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
09/15/2016
Decision Date
03/03/2017
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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