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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 K212752
Device Name Med-link Pulse Oximeter
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th And 5th Floor, Bldg. Two, Hualian Industrial Zone
Xinshi Community, Dalang St.
Shenzhen,  CN 518109
Applicant Contact Jialing Zhang
Correspondent
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th And 5th Floor, Bldg. Two, Hualian Industrial Zone
Xinshi Community, Dalang St.
Shenzhen,  CN 518109
Correspondent Contact Jialing Zhang
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/30/2021
Decision Date 05/20/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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