Vesta RF Cannula

Probe, Radiofrequency Lesion

Biomerics

The following data is part of a premarket notification filed by Biomerics with the FDA for Vesta Rf Cannula.

Pre-market Notification Details

Device IDK190259
510k NumberK190259
Device Name:Vesta RF Cannula
ClassificationProbe, Radiofrequency Lesion
Applicant Biomerics 6030 West Harold Gatty Drive Salt Lake City,  UT  84116
ContactJake Wakley
CorrespondentJake Wakley
Biomerics 6030 West Harold Gatty Drive Salt Lake City,  UT  84116
Product CodeGXI  
CFR Regulation Number882.4725 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyNeurology
510k Review PanelNeurology
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-02-07
Decision Date2020-02-07

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