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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 K213431
Device Name Handheld Pulse Oximeter
Applicant
Shenzhen Witleaf Medical Electronics Co., Ltd.
13/F-B2, Block 1, Senyang Science Park, # 7 Rd.,
West District Of High-Tech Park, Guangming
Shenzhen,  CN 518132
Applicant Contact Wu Tao
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 508, Block C, # 1029 Nanhai Ave., Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/21/2021
Decision Date 02/26/2023
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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