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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 K152415
Device Name Digital Blood Pressure Monitor
Applicant
Suzhou Sunspirit Co., Ltd.
# 72, Hengshan Rd., Suzhou New District
Suzhou,  CN 215009
Applicant Contact Jing Zhang
Correspondent
Shenzhen Hlongmed Biotech Company Limited
R150-08, E. Bldg., Yihai Plaza, Chuangye Rd.,
Nanshan District
Shenzhen,  CN 518054
Correspondent Contact Long Yang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received08/26/2015
Decision Date 05/06/2016
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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