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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
510(k) Number K032733
Device Name PM-8000 PATIENT MONITOR, MODEL 8000
Applicant
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Applicant Contact SUSAN D GOLDSTEIN-FALK
Correspondent
Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
55 Northern Blvd., Suite 200
Great Neck,  NY  11021
Correspondent Contact SUSAN D GOLDSTEIN-FALK
Regulation Number870.2300
Classification Product Code
DRT  
Date Received09/04/2003
Decision Date 03/03/2004
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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