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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 K182495
Device Name Electronic Blood Pressure Monitor
Applicant
Shenzhen Jumper Medical Equipment Co., Ltd.
D Bldg., # 71, Xintian Rd., Fuyong St., Baoan
District
Shenzhen,  CN 518103
Applicant Contact Jinhui Tang
Correspondent
Shenzhen Jumper Medical Equipment Co., Ltd.
D Bldg., # 71, Xintian Rd., Fuyong St., Baoan
District
Shenzhen,  CN 518103
Correspondent Contact Jinhui Tang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received09/11/2018
Decision Date 03/03/2019
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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