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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 K202776
Device Name Fingertip pulse oximeter
Applicant
Shenzhen LEPU Intelligent Medical Equipment Co., Ltd.
North side of floor 3, BLD 9 BaiWangxin High-Tech
Industrial Park, Songbai Roa
Shenzhen,  CN 518055
Applicant Contact Aaron Lin
Correspondent
FDA Regulatory and Quality Systems Consultant
31853 Cedar Road
Mayfield Heights,  OH  44124 -4445
Correspondent Contact Arthur Goddard
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/21/2020
Decision Date 03/01/2021
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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