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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 K881602
Device Name OMRON DIGITAL BLOOD PRESSURE MONITOR MODEL HEM703C
Applicant
Omron Tateisi Electronics Co.
Toranomon 35 Mori Bldg.
3-4-10, Toranomon, Minato-Ku
Tokyo, 105 Japan,  JP
Applicant Contact KUKI
Correspondent
Omron Tateisi Electronics Co.
Toranomon 35 Mori Bldg.
3-4-10, Toranomon, Minato-Ku
Tokyo, 105 Japan,  JP
Correspondent Contact KUKI
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/13/1988
Decision Date 06/15/1988
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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