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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Transducer, Blood-Pressure, Extravascular
510(k) Number K871371
Device Name DIGITAL SPHYGMOMANOMETER
Applicant
Omron Tateisi Electronics Co.
Toranomon 35 Mori Bldg.
3-4-10, Toranomon, Minato-Ku
Tokyo, 105 Japan,  JP
Applicant Contact HISA
Correspondent
Omron Tateisi Electronics Co.
Toranomon 35 Mori Bldg.
3-4-10, Toranomon, Minato-Ku
Tokyo, 105 Japan,  JP
Correspondent Contact HISA
Regulation Number870.2850
Classification Product Code
DRS  
Date Received04/07/1987
Decision Date 06/12/1987
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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