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FDA 510(k) Application Details - K191417
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K191417
Device Name
Oximeter
Applicant
Belun Technology Company Limited
Rm531B, floor 5, Core Building 2, 1 Science Park West Avenue
HK Science Park
Sha Tin HK
Other 510(k) Applications for this Company
Contact
Leung Lap Wai Lydia
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
05/28/2019
Decision Date
10/10/2019
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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