VENDYS MODEL 5000 B/BC

Computer, Diagnostic, Programmable

ENDOTHELIX, INC.

The following data is part of a premarket notification filed by Endothelix, Inc. with the FDA for Vendys Model 5000 B/bc.

Pre-market Notification Details

Device IDK060980
510k NumberK060980
Device Name:VENDYS MODEL 5000 B/BC
ClassificationComputer, Diagnostic, Programmable
Applicant ENDOTHELIX, INC. 2472 BOLSOVER SUITE 439C Houston,  TX  77005
ContactDouglas Blakely
CorrespondentDouglas Blakely
ENDOTHELIX, INC. 2472 BOLSOVER SUITE 439C Houston,  TX  77005
Product CodeDQK  
CFR Regulation Number870.1425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-04-10
Decision Date2007-08-16
Summary:summary

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