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FDA 510(k) Application Details - K151024
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K151024
Device Name
Oximeter
Applicant
TAIDOC TECHNOLOGY CORPORATION
6F, NO. 127, WUGONG 2ND RD., WUGU DISTRICT
NEW TAIPEI CITY 24888 TW
Other 510(k) Applications for this Company
Contact
C. W. 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
04/16/2015
Decision Date
03/02/2016
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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