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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 K002061
Device Name A&D MEDICAL TM-2550/TM-2551/TM-2560 VITAL SENSOR MONITOR
Applicant
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Applicant Contact JERRY WANG
Correspondent
A & D ENGINEERING, INC.
1555 MC CANDLESS DR.
MILPITAS,  CA  95035
Correspondent Contact JERRY WANG
Regulation Number870.2300
Classification Product Code
DRT  
Date Received07/06/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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