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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 K231243
Device Name Finger Clip Pulse Oximeter
Applicant
Guangdong Genial Technology Co., Ltd.
I-6-05-02 11th Road,Area B, Guangfozhao Economic
Cooperation Zone,Zhagang Town,Huaiji County
Zhaoqing,  CN 526437
Applicant Contact Yu Jun
Correspondent
Shenzhen Reanny Medical Devices Management Consulting Co Ltd
Room 1407, Jingting Building, Dongzhou Community
Guangming Street, Guangming District
Shenzhen,  CN 518000
Correspondent Contact Reanny Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/01/2023
Decision Date 10/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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