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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 K221979
Device Name Pulse Oximeter (Model C101A2, C101B1, C101A3)
Applicant
Shenzhen IMDK Medical Technology CO., Ltd.
C Zone 10F, Building 16, Yuanshan Industrial B Area,
Gongming Street, Guangming District
Shenzhen,  CN 518106
Applicant Contact Yuan Xia
Correspondent
Shanghai Truthful Information Technology Co., Ltd.
RM. 1801, No. 161, East Lujiazui Rd., Pudong
Shanghai,  CN 200120
Correspondent Contact Boyle Wang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/05/2022
Decision Date 10/16/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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