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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 K992808
Device Name A&D MEDICAL TM-2430 AND TM-2431 AMBULATORY BLOOD PRESSURE
Applicant
A&D Medical Div.
1555 Mccandless Dr.
Milpitas,  CA  95025
Applicant Contact JERRY WANG
Correspondent
Citech
5200 Butler Pike
Plymouth Meeting,  PA  19462
Correspondent Contact ROBERT MOSENKIS
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/20/1999
Decision Date 09/01/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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