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FDA 510(k) Application Details - K232989
Device Classification Name
Oximeter
More FDA Info for this Device
510(K) Number
K232989
Device Name
Oximeter
Applicant
Shenzhen AOJ Medical Technology Co., Ltd
Rm 301&4F, Block A, Bldg A,ingfa Intelligent Manufacturing
Park,Xiaweiyuan,Gushu Community,Xixiang St, Bao'an District
Shenzhen 518126 CN
Other 510(k) Applications for this Company
Contact
Jack Wang
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
09/22/2023
Decision Date
07/01/2024
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
FDA Source Information for K232989
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