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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 K203854
Device Name Pulse Oximeter
Applicant
Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
Floor 14, Block D, Dianlian Technology Bldg.,
The Crossing Between S. Circle Rd. And S. Fuli Rd.,
Shenzhen,  CN 518106
Applicant Contact John Liu
Correspondent
Shenzhen Hexin Zondan Medical Equipment Co., Ltd.
Floor 14, Block D, Dianlian Technology Bldg.,
The Crossing Between S. Circle Rd. And S. Fuli Rd.,
Shenzhen,  CN 518106
Correspondent Contact John Liu
Regulation Number870.2700
Classification Product Code
DQA  
Date Received12/31/2020
Decision Date 04/23/2021
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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