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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 K152089
Device Name Wrist Pulse Oximeter
Applicant
Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
# 8, Shengchang W. Rd.,Danyang Economy Development Zone
Jiang Su,  CN
Applicant Contact Li Xu
Correspondent
Jiangsu Konsung Bio-Medical Science & Technology Co., Ltd.
# 8, Shengchang W. Rd.,Danyang Economy Development Zone
Jiang Su,  CN
Correspondent Contact Li Xu
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/27/2015
Decision Date 08/17/2016
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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