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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 K202743
Device Name Med-Link Temp-pulse Oximeter
Applicant
Shenzhen Med-Link Electronics Tech Co., Ltd.
4th Snf 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 Snf 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  
Subsequent Product Code
FLL  
Date Received09/18/2020
Decision Date 03/01/2021
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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