PVMED DDR 2430T

Solid State X-ray Imager (flat Panel/digital Imager)

PORTAVISION MEDICAL LLC

The following data is part of a premarket notification filed by Portavision Medical Llc with the FDA for Pvmed Ddr 2430t.

Pre-market Notification Details

Device IDK133524
510k NumberK133524
Device Name:PVMED DDR 2430T
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner,  LA  70065
ContactTerry Ancar
CorrespondentTerry Ancar
PORTAVISION MEDICAL LLC 5401 COCOS PLUMOSAS DRIVE Kenner,  LA  70065
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-15
Decision Date2014-04-16

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