PCA-C1 Series Patient Cable

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

QT Medical, Inc.

The following data is part of a premarket notification filed by Qt Medical, Inc. with the FDA for Pca-c1 Series Patient Cable.

Pre-market Notification Details

Device IDK200722
510k NumberK200722
Device Name:PCA-C1 Series Patient Cable
ClassificationCable, Transducer And Electrode, Patient, (including Connector)
Applicant QT Medical, Inc. 1360 Valley Vista Dr., Suite 203 Diamond Bar,  CA  91765
ContactRuey-kang Chang
CorrespondentRuey-kang Chang
QT Medical, Inc. 1360 Valley Vista Dr., Suite 203 Diamond Bar,  CA  91765
Product CodeDSA  
CFR Regulation Number870.2900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-19
Decision Date2021-06-03

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