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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 K240808
Device Name Pulse Oximeter (WS20A)
Applicant
Hunan Accurate Bio-Medical Technology Co., Ltd.
Accurate Industrial Park, #108, Zhixian Rd.
Xuelian Community, Xueshi St. Of Yuelu District
Changsha,  CN 410208
Applicant Contact Li Zhang
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 504, Block C, # 1029 Nanhai Ave., Nanshan District
Shenzhen,  CN 518067
Correspondent Contact Jie Yang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/25/2024
Decision Date 10/03/2024
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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