Virtual C DRF Digital Imaging System

Interventional Fluoroscopic X-ray System

Portavision Medical LLC

The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Virtual C Drf Digital Imaging System.

Pre-market Notification Details

Device IDK211191
510k NumberK211191
Device Name:Virtual C DRF Digital Imaging System
ClassificationInterventional Fluoroscopic X-ray System
Applicant Portavision Medical LLC 800 Central Avenue Jefferson,  LA  70121
ContactTerry Ancar
CorrespondentDaniel Kamm
Kamm And Associates 8870 Ravello Ct Naples,  FL  34114
Product CodeOWB  
Subsequent Product CodeJAA
Subsequent Product CodeOXO
CFR Regulation Number892.1650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-21
Decision Date2021-06-24

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