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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 K210274
Device Name Fingertip Pulse Oximeter
Applicant
Zhuhai Linte Medical Instrument Co., Ltd.
4th Floor, Building 1, No.66, Yongda Road, Hongqi Town,
Jinwan District
Zhuhai,  CN 519090
Applicant Contact Kezheng Ma
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received02/01/2021
Decision Date 07/30/2021
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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