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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 K201294
Device Name Pulse Oximeter
Applicant
Guangdong Long Yao Electronic Technology Co., Ltd.
Unit A03, 2nd Floor, # 19, Huali Rd., Tianhe District
Guangzhou,  CN 510000
Applicant Contact Lei Wang
Correspondent
Chonconn Medical Device Consulting Co., Ltd.
Rm. 508, Block C, # 1029 Nanhai Ave., Nanshan District,
Shenzhen,  CN 518067
Correspondent Contact Kevin Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/14/2020
Decision Date 11/27/2020
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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