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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 K093102
Device Name AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270
Applicant
NIHON SEIMITSU SOKKI CO., LTD.
3F, 2-17-6 AKEBONO-CHO
TACHIKAWA- SHI, TOKYO,  JP 190-0012
Applicant Contact KOJI KUBO
Correspondent
NIHON SEIMITSU SOKKI CO., LTD.
3F, 2-17-6 AKEBONO-CHO
TACHIKAWA- SHI, TOKYO,  JP 190-0012
Correspondent Contact KOJI KUBO
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/01/2009
Decision Date 06/03/2010
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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