FDA 510(k) Application Details - K232989

Device Classification Name Oximeter

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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
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Contact Jack Wang
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Regulation Number 870.2700

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Classification Product Code DQA
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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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