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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 K071075
Device Name TERUMO DIGITAL BLOOD PRESSURE MONITOR ES-H55A
Applicant
Terumo Corp.
44-1, 2-Chome, Hatagaya
Shibuya-Ku, Tokyo,  JP 151-0072
Applicant Contact YOSHIAKI NAGURA
Correspondent
Kema Quality B.V.
4377 County Line Rd.
Chalfont,  PA  18914
Correspondent Contact J A VAN VUGT
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/16/2007
Decision Date 05/25/2007
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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