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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Recorder, Magnetic Tape, Medical
510(k) Number K073152
Device Name PC-180 / PRINCE 180 EASY ECG MONITOR
Applicant
SHENZHEN CREATIVE INDUSTRY CO., LTD
2/F, BLOCK 3 NANYOU TIAN'
AN INDUSTRY TOWN
SHENZHEN,GD,  CN 518054
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.2800
Classification Product Code
DSH  
Date Received11/08/2007
Decision Date 01/10/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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