The ClearSight Finger Cuffs

System, Measurement, Blood-pressure, Non-invasive

Edwards Lifesciences, LLC

The following data is part of a premarket notification filed by Edwards Lifesciences, Llc with the FDA for The Clearsight Finger Cuffs.

Pre-market Notification Details

Device IDK190130
510k NumberK190130
Device Name:The ClearSight Finger Cuffs
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
ContactChristine J. Chun
CorrespondentChristine J. Chun
Edwards Lifesciences, LLC One Edwards Way Irvine,  CA  92614
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-01-28
Decision Date2019-06-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
50690103199623 K190130 000
50690103199616 K190130 000
50690103199609 K190130 000
50690103203344 K190130 000
50690103203337 K190130 000
50690103203320 K190130 000

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