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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 K150908
Device Name XM-01 Electronic Automatic Blood Pressure Monitor
Applicant
Sky Innovation Technology ( Shanghai) Limited
9th Floor Hechuan Bldg.,
2016 Yishan Rd., Minhang
Shanghai,  CN 201103
Applicant Contact Charles Shen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received04/03/2015
Decision Date 12/16/2015
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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