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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 K173123
Device Name Pulse Oximeter
Applicant
Shenzhen Imdk Medical Technology Co., Ltd.
C Zone, 10f, Bldg. 16, Yuanshan Industrial B Area
Gongming St.
Guangming District, Shenzhen,  CN
Applicant Contact Xia Yuan
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
22a, Haijing Square
# 18, Taizi Rd.
Nanshan District, Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received09/29/2017
Decision Date 08/13/2018
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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