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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 K203652
Device Name Blood Pressure Cuff, U1883S,U1883D, U1882S, U1882D, U1881S, U1881D, Blood Pressure Cuff, U1885S, U1885D, U1880S, U1880D, U1886S, U1886D, Blood Pressure Cuff, U1869S, U1869D, U1889S, U1889D, U1884S, U1884D, Blood Pressure Cuff, U1710S, U1720S, U1730S,U1740S, U1750S, U1760S, Blood Pressure Cuff, U1770S, U1790s, U1710D, U1720D, U1730D, U1740D
Applicant
Jkh USA, LLC
20505 Valley Blvd. Suite 108
Walnut,  CA  91789
Applicant Contact Bill Quanqin Dai
Correspondent
Jkh USA, LLC
14271 Jeffrey Rd.
#246
Irvine,  CA  92620
Correspondent Contact Bill Quanqin Dai
Regulation Number870.1120
Classification Product Code
DXQ  
Date Received12/14/2020
Decision Date 01/06/2021
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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