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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 K190869
Device Name Pulse Oximeter
Applicant
Shenzhen Aeon Technology Co., Ltd.
Rm6h02, Block 27-29, Tianxia Ic Industrial Park, Majialong
#133 Of Yiyuan Rd., Nantou St., Nanshan District
Shenzhen,  CN 518052
Applicant Contact Xie Hua
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
# 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 Received04/03/2019
Decision Date 09/13/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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