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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K913844
Device Name ACCUTRACKER DX
Applicant
Suntech Medical Instruments, Inc.
8608 Jersey Ct.
Raleigh,  NC  27613
Applicant Contact CHRIS MCNEELY
Correspondent
Suntech Medical Instruments, Inc.
8608 Jersey Ct.
Raleigh,  NC  27613
Correspondent Contact CHRIS MCNEELY
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/28/1991
Decision Date 07/14/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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