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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 K231979
Device Name Mecun SpO2 sensor
Applicant
Shenzhen Mecun Medical Supply Co., Ltd.
2nd Level, 2nd Bldg., Fuqiang S&T Park, 6 Ailian
Industrial Park, Zhugushi, Wulian Community
Shenzhen,  CN 518000
Applicant Contact Zheng Bo
Correspondent
Shenzhen Mecun Medical Supply Co., Ltd.
2nd Level, 2nd Bldg., Fuqiang S&T Park, 6 Ailian
Industrial Park, Zhugushi, Wulian Community
Shenzhen,  CN 518000
Correspondent Contact Zheng Bo
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/05/2023
Decision Date 08/16/2024
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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