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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 K213430
Device Name Fingertip Pulse Oximeter
Applicant
Shenzhen Witleaf Medical Electronics Co.,Ltd
13/F-B2, Block 1, Senyang Science Park, No.7 Road, West
District of High-Tech Park, Guangming
Shenzhen,  CN 518132
Applicant Contact Wu Tao
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 Received10/21/2021
Decision Date 12/30/2022
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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