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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 K251751
Device Name Spo2 Sensor CSS032D
Applicant
Shenzhen Ykd Technology Co., Ltd.
6f, Bldg. 6, Huaxinruiming Industrial Area, Langrong Rd.,
Xinwei Village, Dalang Community Dalang St., Longhua Dist
Shenzhen,  CN 518000
Applicant Contact Long Zhao
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.2401 Zhenye International Business Center,
# 3101-90 Qianhai Rd.
Shenzhen,  CN 518052
Correspondent Contact Youshan Gong
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/09/2025
Decision Date 12/19/2025
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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