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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 K150430
Device Name Arm Blood Pressure Monitor, Wrist Blood Pressure Monitor
Applicant
Fudakang Industrial Co., Ltd.
No 8 Yinghe Rd., Yuanjiangyuan
Management Zone, Changping Town
Dongguan,  CN 523560
Applicant Contact BOB YU
Correspondent
Shenzhen Joyantech Consulting Co., Ltd.
4th Floor, Jinhui Bldg. Nanhai Blvd., Nanshan District
Shenzhen,  CN 518100
Correspondent Contact MR. FIELD FU
Regulation Number870.1130
Classification Product Code
DXN  
Date Received02/19/2015
Decision Date 04/17/2015
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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