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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter
510(k) Number K200414
Device Name Pulse Oximeter
Applicant
Shenzhen Aeon Technology Co., Ltd.
RM6H02, Block 27-29, Tianxia IC Industrial Park, Majialong
No.133 of Yiyuan road, Nantou Street, Nanshan District
Shenzhen,  CN 518000
Applicant Contact Xie Hua
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
No. A415, Block A, NanShan Medical devices Industrial Park
Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/19/2020
Decision Date 09/23/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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