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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 K102854
Device Name PC ECG
Applicant
Edan Instruments, Inc.
Nanhai Rd. 1019#
Nanshen
Shenzhen, Guangdong,  CN 518067
Applicant Contact YUE QIUHONG (TRACY)
Correspondent
Edan Instruments, Inc.
Nanhai Rd. 1019#
Nanshen
Shenzhen, Guangdong,  CN 518067
Correspondent Contact YUE QIUHONG (TRACY)
Regulation Number870.2340
Classification Product Code
DPS  
Date Received09/29/2010
Decision Date 12/03/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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