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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph, Ambulatory (Without Analysis)
510(k) Number K992584
Device Name PE 501 PC-ECG MONITOR
Applicant
Nhe Corp.
7100 Fernwood Ave.
Suite 1922
Richmond,  VA  23228
Applicant Contact SHUGEN ZHANG
Correspondent
Nhe Corp.
7100 Fernwood Ave.
Suite 1922
Richmond,  VA  23228
Correspondent Contact SHUGEN ZHANG
Regulation Number870.2800
Classification Product Code
MWJ  
Date Received08/02/1999
Decision Date 01/13/2000
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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