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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K160876
Device Name PC ECG
Applicant
Edan Instruments, Inc.
3/F - B, Nanshan Medical Equipments Park
Nanhai Rd. 1019#
Shenzhen,  CN 518067
Applicant Contact QUEENA CHEN
Correspondent
Edan Medical
1200 Crossman Ave.
Suite 200
Sunnyvale,  CA  94089
Correspondent Contact DOUG WORTH
Regulation Number870.2340
Classification Product Code
DPS  
Date Received03/30/2016
Decision Date 02/15/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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