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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Blood Pressure Cuff
510(k) Number K190902
Device Name RH non-Automated Blood Pressure Meter RH non-Automated Blood Pressure Meter with Stethoscope
Applicant
Wenzhou Renhua Instruments Co., Ltd.
#.1-1704 Wanda Business Bldg. Yongding Rd.,
Longwan
Wenzhou,  CN 325024
Applicant Contact Wang Saijie
Correspondent
Wenzhou Renhua Instruments Co., Ltd.
#.1-1704 Wanda Business Bldg. Yongding Rd.,
Longwan
Wenzhou,  CN 325024
Correspondent Contact Wang Saijie
Regulation Number870.1120
Classification Product Code
DXQ  
Subsequent Product Code
LDE  
Date Received04/08/2019
Decision Date 05/22/2019
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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