Patient Monitoring Cables

Cable, Transducer And Electrode, Patient, (including Connector)

JKH USA, LLC

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

Pre-market Notification Details

Device IDK203635
510k NumberK203635
Device Name:Patient Monitoring Cables
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
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 CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-14
Decision Date2021-02-05

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