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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 K171241
Device Name Pulse Oximeter
Applicant
Hunan Accurate Bio-Medical Technology Co., Ltd.
M8-613, No.8, Lutian Road, Changsha National
Hi-Tech Industrial Development
Changsha,  CN 410208
Applicant Contact Zhou Le
Correspondent
Hunan Accurate Bio-Medical Technology Co., Ltd.
M8-613, No.8, Lutian Road, Changsha National
Hi-Tech Industrial Development
Changsha,  CN 410208
Correspondent Contact Zhou Le
Regulation Number870.2700
Classification Product Code
DQA  
Date Received04/27/2017
Decision Date 03/27/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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