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,

Blood Pressure Cuff

JKH USA, LLC

The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA for 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,.

Pre-market Notification Details

Device IDK203652
510k NumberK203652
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,
ClassificationBlood Pressure Cuff
Applicant JKH USA, LLC 20505 Valley Blvd. Suite 108 Walnut,  CA  91789
ContactBill Quanqin Dai
CorrespondentBill Quanqin Dai
JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine,  CA  92620
Product CodeDXQ  
CFR Regulation Number870.1120 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-14
Decision Date2021-01-06

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