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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 K210305
Device Name Pulse Oximeter
Applicant
Dongguan Lingxin Technologies Co., LTD
Room 301, No. 3 Liantang Road, Aoshitang, Dongcheng Street
Dongguan,  CN 523129
Applicant Contact Cony Tang
Correspondent
Shenzhen Reanny Medical Devices Mangement Consulting., Ltd
Room 1813 of Gebu commercial building, Hongxing,
Songgang Street, Baoan District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/03/2021
Decision Date 12/22/2021
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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