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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 K213984
Device Name Oximeter (Model: JZK-301,JZK-303,JZK-305,JZK-307)
Applicant
Shenzhen Zhengkang Technology Co., Ltd.
2&3/F, Bldg. A, # 3 Fuxing Yi Ln., Hehua Community,
Pinghu St., Longgang District
Shenzhen,  CN 518100
Applicant Contact Huayong Yang
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rm.218, Bldg. 2, Yike Intelligent Innovation Park,
# 232 Kezhu Rd., Huangpu
Guangzhou,  CN 510000
Correspondent Contact Becky Chen
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/20/2021
Decision Date 12/16/2022
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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